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Clinical Trial Results:
An international multi-center, open-label study to evaluate safety, tolerability, biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201 for the therapy of somatostatin receptor positive neuroendocrine tumours (NETs).

Summary
EudraCT number	2015-002867-41
Trial protocol	AT GB DK
Global end of trial date	22 Feb 2022

Results information
Results version number	v1(current)
This version publication date	10 Mar 2023
First version publication date	10 Mar 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

OPS-C-001/D-FR-01072-001

ISRCTN number

US NCT number

NCT02592707

WHO universal trial number (UTN)

Sponsor organisation name

Ipsen Pharma

Sponsor organisation address

65, quai Georges Gorse, Boulogne Billancourt, France, 92100

Public contact

Medical Director, Ipsen Pharma, clinical.trials@ipsen.com

Scientific contact

Medical Director, Ipsen Pharma, clinical.trials@ipsen.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

22 Feb 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

22 Feb 2022

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess the safety and tolerability of peptide receptor radionuclide therapy (PRRT) with 177Lu-OPS201 administered in 3 cycles in participants with somatostatin receptor (sstr) subtype 2-positive NETs (including phaechromocytomas and paragangliomas).

Protection of trial subjects

The study was conducted under the provisions of the Declaration of Helsinki, in accordance with the International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice and in compliance with Independent Ethics Committees/Institutional Review Boards and informed consent regulations.

Background therapy

Evidence for comparator

Actual start date of recruitment

06 Mar 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 12

Country: Number of subjects enrolled

Canada: 1

Country: Number of subjects enrolled

Switzerland: 5

Country: Number of subjects enrolled

United Kingdom: 5

Country: Number of subjects enrolled

Austria: 2

Country: Number of subjects enrolled

Denmark: 4

Country: Number of subjects enrolled

France: 11

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This Phase 1/2, open-label study was conducted in participants with somatostatin receptor positive NETs at 8 investigational sites between 06 March 2017 and 22 February 2022. The sponsor terminated the study early for strategic reasons and this decision was not due to any safety or tolerability concern of the study drug.

Screening details

This was 2-part study, Part A and B. Study consisted of a screening period (up to 4 weeks), treatment period (3 core treatment cycles in Part A and B;2 additional cycles in Part B only: up to 30 months) and followed by long-term follow-up (LTFU) period (2 years). A total of 40 participants were treated.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part A

Arm description

Participants received 4.5 gigabecquerel (GBq) 177Lu-IPN01072 [target dose of 300 microgram (mcg) ±50 mcg] intravenous (IV) infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart [+2 weeks or up to +4 weeks in case of adverse events (AE) which had not adequately recovered].

Arm type

Experimental

Investigational medicinal product name

177Lu-IPN01072

Investigational medicinal product code

Other name

177Lu-OPS201

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

The study medication formulation consisted of 4.5 GBq of 177Lu-IPN01072 in a total volume of 20 milliliter (mL) that was administered by IV infusion over 120 minutes. The overall infusion duration did not exceeded 4 hours.

Cohort 1: Part B

Arm description

Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by data review board (DRB). As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).

Arm type

Experimental

Investigational medicinal product name

177Lu-IPN01072

Investigational medicinal product code

Other name

177Lu-OPS201

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

The study medication formulation consisted of 6 GBq of 177Lu-IPN01072 in a total volume of 20 mL that was administered by IV infusion over 120 minutes. The overall infusion duration did not exceeded 4 hours.

Cohort 3: Part B

Arm description

Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 700 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).

Arm type

Experimental

Investigational medicinal product name

177Lu-IPN01072

Investigational medicinal product code

Other name

177Lu-OPS201

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

The study medication formulation consisted of 4.5 GBq of 177Lu-IPN01072 in a total volume of 20 mL that was administered by IV infusion over 120 minutes. The overall infusion duration did not exceeded 4 hours.

Cohort 6: Part B

Arm description

Participants received of 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg in Cycle 1; 1300 mcg in Cycle 2; 300 mcg in Cycle 3) IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).

Arm type

Experimental

Investigational medicinal product name

177Lu-IPN01072

Investigational medicinal product code

Other name

177Lu-OPS201

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Number of subjects in period 1	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B
Started	15	6	9	10
Completed	9	1	3	3
Not completed	6	5	6	7
Consent withdrawn by subject	-	1	2	-
Never entered LTFU period	1	-	-	2
Death	1	-	-	-
Progressive Disease	4	4	3	3
Unspecified	-	-	1	2

Baseline characteristics

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Reporting group title

Part A

Reporting group description

Reporting group title

Cohort 1: Part B

Reporting group description

Reporting group title

Cohort 3: Part B

Reporting group description

Reporting group title

Cohort 6: Part B

Reporting group description

Reporting group values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	Total
Number of subjects	15	6	9	10	40
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	7	3	6	7	23
From 65-84 years	8	3	3	3	17
85 years and over	0	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	62.7 ( 12.9 )	65.3 ( 8.9 )	55.0 ( 16.0 )	56.7 ( 13.7 )	-
Gender categorical
Units: Subjects
Female	8	2	3	6	19
Male	7	4	6	4	21
Race
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Black or African American	0	0	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
White	15	6	9	9	39
Other	0	0	0	0	0
Ethnicity
Units: Subjects
Not Hispanic or Latino	15	6	9	10	40

End points

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Reporting group title

Part A

Reporting group description

Reporting group title

Cohort 1: Part B

Reporting group description

Reporting group title

Cohort 3: Part B

Reporting group description

Reporting group title

Cohort 6: Part B

Reporting group description

Subject analysis set title

All Participants

Subject analysis set type

Full analysis

Subject analysis set description

Participants who received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose of 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles/additional 2 cycles (when applicable). Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).

Subject analysis set title

Part B: All Participants

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received 177Lu-IPN01072 dose from 4.5 to 6 GBq (target dose from 300 to 1300 mcg) as IV infusion on Day 1 of 3 treatment cycles. Target dose was 300 mcg for additional cycles, if any. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

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End point title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs ^[1]

End point description

AE is defined as any untoward medical occurrence in a subject or clinical trial subject administered a medicinal product, which did not necessarily have a causal relationship with this treatment. A serious AE (SAE) was classified as any untoward medical occurrence that at any dose results in death; AE was life threatening; required inpatient hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was an important medical event that may not result in death. TEAEs are defined as AEs that developed or worsened after start of treatment. The SAS included all participants who received 177Lu-IPN01072.

End point type

Primary

End point timeframe

From the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, maximum of 33 months.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparisons between the treatment groups was performed for safety endpoints.

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	15	6	9	10	40
Units: participants
number (not applicable)
TEAEs	15	6	9	10	40
Serious TEAEs	2	1	2	3	8

No statistical analyses for this end point

Primary: Number of Participants With Dose Limiting Toxicities (DLT)

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End point title

Number of Participants With Dose Limiting Toxicities (DLT) ^[2]

End point description

DLTs were defined as study medication-related AEs with a severity of Grade 3 or higher are considered DLT, with the exception of hair loss, lymphopenia, nonfebrile neutropenia lasting <4 weeks and thrombocytopenia lasting <4 weeks. The SAS included all participants who received 177Lu-IPN01072.

End point type

Primary

End point timeframe

From the start of the first study medication (Cycle 1 Day 1) up to EOCT, maximum of 16 weeks.

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparisons between the treatment groups was performed for safety endpoints.

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	15	6	9	10	40
Units: participants
number (not applicable)	3	0	2	1	6

No statistical analyses for this end point

Secondary: Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1

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End point title

Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1

End point description

177Lu-IPN01072 uptake in organs and lesions was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Uptake activity for organs of interest (i.e., body, bone marrow, kidney (left + right), healthy liver, and spleen) was determined. The maximal uptake in lesions was calculated for each lesion as: maximal activity divided injected activity*100. The Per Protocol Dosimetry Analysis set (PP-DAS) included all participants in the Intent-To-Treat Dosimetry Analysis set (ITT-DAS) for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported. 99999 indicates no participants were analyzed. Here, ‘n’ = number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	11	6	9	10	36
Units: percentage of injected drug activity
median (full range (min-max))
Bone marrow (image based ) (n = 11, 6, 6, 6, 29)	0.0469 (0.0246 to 0.0751)	0.0420 (0.0100 to 0.280)	0.0250 (0.0149 to 0.0570)	0.0219 (0.0053 to 0.0300)	0.0380 (0.0053 to 0.280)
Liver (n = 7, 1, 0, 0, 8)	1.52 (0.314 to 6.34)	4.31 (4.31 to 4.31)	99999 (99999 to 99999)	99999 (99999 to 99999)	2.63 (0.314 to 6.34)
Kidney (left + right) (n = 11, 6, 9, 9, 35)	1.96 (0.980 to 3.82)	1.76 (1.05 to 2.08)	1.60 (1.19 to 2.51)	1.67 (0.749 to 2.41)	1.76 (0.749 to 3.82)
Spleen (n = 9, 6, 6, 6, 27)	1.50 (0.274 to 2.93)	1.27 (0.960 to 2.46)	1.78 (0.550 to 5.97)	1.79 (1.19 to 2.65)	1.67 (0.274 to 5.97)
All lesions (n = 11, 5, 9, 8, 33)	0.651 (0.0290 to 6.35)	2.36 (0.266 to 8.74)	1.18 (0.235 to 18.7)	1.43 (0.190 to 15.0)	0.932 (0.0290 to 18.7)

No statistical analyses for this end point

Secondary: Maximal Uptake (%) of 177Lu-IPN01072 of Blood in Cycle 1

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End point title

Maximal Uptake (%) of 177Lu-IPN01072 of Blood in Cycle 1

End point description

177Lu-IPN01072 uptake in blood was evaluated on site/locally using a gamma counter calibrated for 177Lu-IPN01072 according to the dosimetry operational manual. The radiopharmaceutical pharmacokinetic (PK) set included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood. Only data from the participants analyzed were reported.

End point type

Secondary

End point timeframe

Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	13	6	8	10	37
Units: percentage/liter (L)
median (full range (min-max))	3.66 (2.17 to 7.88)	2.98 (2.26 to 4.35)	2.77 (1.98 to 7.35)	3.32 (0.539 to 4.11)	3.03 (0.539 to 7.88)

No statistical analyses for this end point

Secondary: Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1

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End point title

Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1

End point description

The AUC of 177Lu-IPN01072 radioactivity in discernible organs were computed for each administration of 177Lu-IPN01072. The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported. 99999 indicates no participants were analyzed. Here, ‘n’ = number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	11	6	9	10	36
Units: Megabecquerel (MBq)*hour
median (full range (min-max))
Bone marrow (image based) (n = 11, 6, 6, 6, 29)	174 (45.3 to 224)	352 (154 to 3988)	138 (91.0 to 362)	157 (41.5 to 244)	175 (41.5 to 3988)
Kidney (left + right) (n = 11, 6, 9, 9, 35)	9596 (3896 to 26596)	8966 (7350 to 10586)	6239 (5853 to 11269)	7578 (3320 to 9815)	8239 (3320 to 26596)
Liver (n = 7, 1, 0, 0, 8)	6745 (755 to 20751)	17918 (17918 to 17918)	99999 (99999 to 99999)	99999 (99999 to 99999)	11133 (755 to 20751)
Spleen (n = 9, 6, 6, 6, 27)	6701 (1134 to 21451)	7949 (4945 to 11734)	7727 (1547 to 28269)	8179 (3901 to 12355)	7772 (1134 to 28269)

No statistical analyses for this end point

Secondary: AUC of 177Lu-IPN01072 in Blood in Cycle 1

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End point title

AUC of 177Lu-IPN01072 in Blood in Cycle 1

End point description

The AUC of 177Lu-IPN01072 radioactivity in blood were computed for each administration of 177Lu-IPN01072. The radiopharmaceutical PK set included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood. Only data from the participants analyzed were reported.

End point type

Secondary

End point timeframe

Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	13	6	8	10	37
Units: MBq*hour/L
median (full range (min-max))	623 (299 to 1003)	901 (442 to 1806)	690 (371 to 1201)	720 (290 to 1034)	726 (290 to 1806)

No statistical analyses for this end point

Secondary: Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1

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End point title

Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1

End point description

The terminal half-life was defined as the largest half-life of the decay curve of blood activity. The radiopharmaceutical PK set included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood. Only data from the participants analyzed were reported.

End point type

Secondary

End point timeframe

Pre-infusion (Baseline), 5 and 30 minutes, 1, 4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	13	6	8	10	37
Units: hours
median (full range (min-max))	68.3 (42.2 to 160)	109 (38.6 to 160)	123 (41.2 to 160)	145 (55.3 to 160)	127 (38.6 to 160)

No statistical analyses for this end point

Secondary: Highest Absorbed Dose of 177LU-OPS201 to Each Discernible Organ in Cycle 1

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End point title

Highest Absorbed Dose of 177LU-OPS201 to Each Discernible Organ in Cycle 1

End point description

The absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. The organs considered for 177LU-OPS201 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables.

End point type

Secondary

End point timeframe

4, 24, 48, 72 to 96 and 144 to 168 hours post infusion in Cycle 1

End point values	All Participants
Number of subjects analysed	36
Units: Gray
number (not applicable)
Bone (image-based assay)	3.59
Kidney (left + right)	8.07
Liver	1.26
Spleen	8.07

No statistical analyses for this end point

Secondary: Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1

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End point title

Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1

End point description

The specific absorbed dose was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Data are presented for all lesions, regardless of their anatomical localization. The organs considered for 177LUOPS201 image-based dosimetry assessment included: liver, bone marrow, kidney (left + right), and spleen. The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported. 99999 indicates no participants were analyzed. Here, ‘n’ = number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycle 1

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	11	6	9	10	36
Units: Gray/GBq
median (full range (min-max))
Lesions (n = 11, 5, 9, 8, 33)	2.56 (0.431 to 14.3)	3.90 (1.92 to 83.3)	6.82 (2.07 to 28.2)	13.5 (2.20 to 81.0)	5.00 (0.431 to 83.3)
Bone marrow (image based) (n = 11, 6, 6, 6, 29)	0.0796 (0.0431 to 0.216)	0.135 (0.0900 to 0.610)	0.0850 (0.0700 to 0.110)	0.0650 (0.0100 to 0.150)	0.0900 (0.0100 to 0.610)
Kidney (left + right) (n = 11, 6, 9, 9, 35)	1.05 (0.522 to 1.85)	0.720 (0.600 to 1.02)	0.880 (0.460 to 1.18)	0.765 (0.420 to 1.10)	0.879 (0.420 to 1.85)
Liver (n = 7, 1, 0, 0, 8)	0.186 (0.146 to 0.279)	0.170 (0.170 to 0.170)	99999 (99999 to 99999)	99999 (99999 to 99999)	0.179 (0.146 to 0.279)
Spleen (n = 9, 6, 6, 6, 27)	0.769 (0.208 to 1.79)	0.945 (0.500 to 1.08)	0.985 (0.180 to 1.46)	0.805 (0.360 to 0.980)	0.840 (0.180 to 1.79)

No statistical analyses for this end point

Secondary: Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

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End point title

Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

End point description

The cumulative absorbed dose in the discernible organs (i.e., organs showing uptake) was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. The PP-DAS included all participants in the ITT-DAS for whom no major protocol violations occurred affecting dosimetry variables. Only data from the participants analyzed were reported. 99999 indicates no participants were analyzed. Cycle (C). Here, ‘n’ = number of participants analyzed at specific time point.

End point type

Secondary

End point timeframe

4, 24, 48, 72 to 96 hours, 144 to 168 hours post infusion in Cycles 1 and 3

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	11	6	9	10	36
Units: Gray
median (full range (min-max))
C1:Bone marrow (image based) (n = 11, 6, 6, 6, 29)	0.319 (0.102 to 0.974)	0.715 (0.390 to 3.59)	0.375 (0.260 to 0.500)	0.285 (0.0400 to 0.690)	0.400 (0.4000 to 3.59)
C1:Kidney (left + right) (n = 11, 6, 9, 9, 35)	4.31 (2.17 to 8.07)	3.85 (3.36 to 4.58)	3.25 (1.79 to 5.34)	3.55 (1.74 to 4.88)	3.73 (1.74 to 8.07)
C1:Liver (n = 7, 1, 0, 0, 8)	0.720 (0.336 to 1.26)	0.810 (0.810 to 0.810)	99999 (99999 to 99999)	99999 (99999 to 99999)	0.765 (0.336 to 1.26)
C1:Spleen (n = 9, 6, 6, 6, 27)	2.88 (0.844 to 8.07)	4.35 (3.17 to 6.00)	4.00 (0.710 to 5.90)	3.55 (1.48 to 4.09)	3.45 (0.710 to 8.07)
C3:Bone marrow (image based) (n = 11, 1, 6, 3, 21)	1.11 (0.636 to 2.17)	1.48 (1.48 to 1.48)	1.09 (0.830 to 1.24)	0.840 (0.290 to 1.23)	1.10 (0.290 to 2.17)
C3:Kidney (left + right) (n = 11, 1, 8, 5, 25)	12.3 (7.67 to 24.1)	9.41 (9.41 to 9.41)	8.91 (6.29 to 14.0)	10.1 (6.95 to 11.5)	10.8 (6.29 to 24.1)
C3:Liver (n = 7, 0, 0, 0, 7)	2.08 (1.01 to 4.14)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	2.08 (1.01 to 4.14)
C3:Spleen (n = 9, 1, 5, 3, 18)	6.93 (4.99 to 15.6)	7.58 (7.58 to 7.58)	9.21 (2.82 to 14.6)	8.08 (5.66 to 14.2)	8.32 (2.82 to 15.6)

No statistical analyses for this end point

Secondary: Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1

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End point title

Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1

End point description

Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 only. The Radiopharmaceutical PK set (Part A and Part B) included all participants in the ITT set who received at least 1 dose of study medication and had at least 1 measured radioactive concentration in blood.

End point type

Secondary

End point timeframe

0 to 6 hours, 6 to 24 hours, 24 to 48 hours post-infusion in Cycle 1 of Part A; 0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part B.

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	13	6	8	9	36
Units: Mbq
median (full range (min-max))	2586 (1722 to 4450)	3106 (2558 to 3998)	2640 (1346 to 3375)	2621 (471 to 3181)	2787 (471 to 4450)

No statistical analyses for this end point

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1

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End point title

Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1

End point description

The PK sampling was performed from Day 1 to Day 3 post infusion done at Cycle 1 for Part B only. The IPN01072 PK set in plasma (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and have no major protocol deviations affecting the plasma PK variables and who had a sufficient number of plasma levels to estimate the main PK parameters. Only data from the participants analyzed were reported.

End point type

Secondary

End point timeframe

Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

End point values	Part B: All Participants
Number of subjects analysed	16
Units: hours
median (full range (min-max))	0.083 (0.00 to 0.28)

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1

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End point title

Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1

End point description

End point type

Secondary

End point timeframe

Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

End point values	Part B: All Participants
Number of subjects analysed	16
Units: nanogram (ng)/milliliter (mL)
arithmetic mean (standard deviation)	10.7 ( 5.47 )

No statistical analyses for this end point

Secondary: AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1

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End point title

AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1

End point description

End point type

Secondary

End point timeframe

Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

End point values	Part B: All Participants
Number of subjects analysed	15
Units: ng*hour (h)/mL
arithmetic mean (standard deviation)	45.8 ( 20.6 )

No statistical analyses for this end point

Secondary: T1/2 of IPN01072 in Cycle 1

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End point title

T1/2 of IPN01072 in Cycle 1

End point description

End point type

Secondary

End point timeframe

Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

End point values	Part B: All Participants
Number of subjects analysed	15
Units: hours
arithmetic mean (standard deviation)	6.09 ( 1.59 )

No statistical analyses for this end point

Secondary: Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1

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End point title

Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1

End point description

End point type

Secondary

End point timeframe

Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

End point values	Part B: All Participants
Number of subjects analysed	15
Units: L/h
arithmetic mean (standard deviation)	9.58 ( 12.8 )

No statistical analyses for this end point

Secondary: Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1

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End point title

Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1

End point description

End point type

Secondary

End point timeframe

Pre-infusion (Baseline) and 5 minutes, 30 minutes, 60 minutes, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours after the end of the infusion in Cycle 1

End point values	Part B: All Participants
Number of subjects analysed	15
Units: Liter
arithmetic mean (standard deviation)	68.7 ( 52.0 )

No statistical analyses for this end point

Secondary: Ae (0-48h) of IPN01072 in Cycle 1

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End point title

Ae (0-48h) of IPN01072 in Cycle 1

End point description

Urine was collected during the first 48 hours post infusion to determine the renal excretion of 177Lu-IPN01072 at Cycle 1 for Part B only. The IPN01072 PK set in urine (Part B only) included all participants in the ITT set who received at least 1 dose of study medication and had no major protocol deviations affecting the urine PK variables and who had all urine IPN01072 levels available to estimate the main urine PK parameters.

End point type

Secondary

End point timeframe

0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 of Part B

End point values	Part B: All Participants
Number of subjects analysed	23
Units: mcg
arithmetic mean (standard deviation)	141 ( 65.9 )

No statistical analyses for this end point

Secondary: Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1

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End point title

Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1

End point description

End point type

Secondary

End point timeframe

0 to 4 hours, 4 to 24 hours, 24 to 48 hours in Cycle 1 in Part B

End point values	Part B: All Participants
Number of subjects analysed	23
Units: percentage of drug excreted into urine
arithmetic mean (standard deviation)	52.9 ( 24.2 )

No statistical analyses for this end point

Secondary: Overall Response Rate (ORR)

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End point title

Overall Response Rate (ORR)

End point description

The ORR was defined as the percentage of participants who achieved a complete response (CRs) or a partial response (PR) as best overall response (BOR) according centralized to response evaluation criteria in solid tumours (RECIST) version 1.1 from investigator assessment. Participants with no tumour assessment after the start of study treatment were not evaluated. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ITT included all participants in the eligible participants set who received study medication.

End point type

Secondary

End point timeframe

From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	15	6	9	10	40
Units: percentage of participants
number (confidence interval 95%)	40.0 (16.3 to 67.7)	16.7 (0.4 to 64.1)	22.2 (2.8 to 60.0)	40.0 (12.2 to 73.8)	32.5 (18.6 to 49.1)

No statistical analyses for this end point

Secondary: Disease Control Rate (DCR)

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End point title

Disease Control Rate (DCR)

End point description

The DCR was defined as the percentage of participants who achieved a CR, a PR or a stable disease (SD) as BOR according to Investigator assessment RECIST version 1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. The ITT included all participants in the eligible participants set who received study medication.

End point type

Secondary

End point timeframe

From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	15	6	9	10	40
Units: percentage of participants
number (confidence interval 95%)	93.3 (68.1 to 99.8)	100.0 (54.1 to 100.0)	100.0 (66.4 to 100.0)	90.0 (55.5 to 99.7)	95.0 (83.1 to 99.4)

No statistical analyses for this end point

Secondary: Best Overall Response

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End point title

Best Overall Response

End point description

The BOR according to RECIST v1.1 was defined as the best response recorded from the initiation of treatment until the EOCT/end of additional cycles (EOAC)/early withdrawal (EW) Visit (during the core study part), prior to the Investigator assessment of progressive disease (PD). Progression was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The ITT included all participants in the eligible participants set who received study medication.

End point type

Secondary

End point timeframe

From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	15	6	9	10	40
Units: count of participants
number (not applicable)
PR	6	1	2	4	13
SD	8	5	7	5	25
PD	1	0	0	0	1
Not Evaluable (NE)	0	0	0	1	1

No statistical analyses for this end point

Secondary: Progression Free Survival (PFS)

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End point title

Progression Free Survival (PFS)

End point description

The PFS was defined as the time from start of study treatment until occurrence of tumour progression or death, according to Investigator assessment RECIST version 1.1. Estimation of the median was based on the Kaplan-Meier method. The ITT included all participants in the eligible participants set who received study medication. 99999 indicates upper limit of CI are non-estimable.

End point type

Secondary

End point timeframe

From the start of the first study medication (Cycle 1 Day 1) up to 2 years after the EOCT/death or lost to follow-up, maximum of 59 months.

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	6	3	6	5	20
Units: months
median (confidence interval 95%)	29.7 (17.5 to 99999)	21.2 (19.4 to 22.4)	25.1 (5.1 to 99999)	11.1 (5.1 to 99999)	28.1 (20.0 to 99999)

No statistical analyses for this end point

Secondary: Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit

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End point title

Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit

End point description

The European Organisation for Research and Treatment of Cancer (EORTC) score QLQ-C30 was used for QoL evaluation. Each scale in the questionnaire was scored (0 to 100) according to the EORTC recommendations in the EORTC QLQ-C30 scoring manual. The scale included a global health status, where high score for the global health status represents a high QoL. The functional scales consisted of physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, where a higher value reflected a better level of function. 9 symptoms scales included nausea and vomiting, pain, fatigue, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties, where a higher value reflected worse symptoms. The ITT set. Only data from the participants analyzed were reported. 99999 indicates that standard deviation could not be calculated as only 1 participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day 1) and EOCT visit (30 months)

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	13	1	8	4	26
Units: score on a scale
arithmetic mean (standard deviation)
Global Health Status	1.27 ( 23.54 )	16.70 ( 99999 )	-6.24 ( 14.61 )	29.15 ( 28.43 )	3.84 ( 23.83 )
Physical functioning	-2.05 ( 11.03 )	0.00 ( 99999 )	-0.82 ( 6.61 )	10.00 ( 20.00 )	0.26 ( 11.70 )
Role functioning	3.85 ( 29.79 )	0.00 ( 99999 )	-0.01 ( 19.90 )	12.50 ( 25.00 )	3.85 ( 25.08 )
Emotional functioning	11.52 ( 30.15 )	-25.00 ( 99999 )	-4.16 ( 7.74 )	10.43 ( 12.51 )	5.12 ( 23.70 )
Cognitive functioning	6.41 ( 19.89 )	0.00 ( 99999 )	-6.26 ( 12.43 )	12.50 ( 15.95 )	3.20 ( 17.66 )
Social functioning	15.38 ( 33.65 )	0.00 ( 99999 )	-2.09 ( 5.90 )	12.50 ( 25.00 )	8.97 ( 26.35 )

No statistical analyses for this end point

Secondary: Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit

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End point title

Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit

End point description

The GI.NET21 module was intended for use among participants with gastrointestinal related (GI.- related) neuroendocrine tumours, who vary in disease stage and treatments. The module comprises 21 questions, consisting of 5 scales (endocrine symptoms, G.I. symptoms, treatment related symptom, social function, disease related worries) and 4 single items that assessed muscle /bone pain symptom, sexual function, information/communication function, and body image. Each question was quoted from 1 (not at all) to 4 (very much). Each scale was scored from 0 to 100. A higher value was equivalent to worse or more problems. Baseline was defined as the last non-missing measurement collected prior to the first dose of study drug (Day 1). The ITT included all participants in the eligible participants set who received study medication. Only data from the participants analyzed were reported. 99999 indicates that standard deviation could not be calculated as only 1 participant was analyzed.

End point type

Secondary

End point timeframe

Baseline (Day 1) and EOCT visit (30 months)

End point values	Part A	Cohort 1: Part B	Cohort 3: Part B	Cohort 6: Part B	All Participants
Number of subjects analysed	13	1	8	4	26
Units: score on a scale
arithmetic mean (standard deviation)
Endocrine symptoms	-5.12 ( 13.31 )	11.10 ( 99999 )	-0.00 ( 5.93 )	-5.55 ( 11.10 )	-2.98 ( 11.13 )
G. I. symptoms	-3.58 ( 13.49 )	-6.70 ( 99999 )	2.50 ( 7.04 )	-13.30 ( 17.22 )	-3.33 ( 12.81 )
Treatment related symptom	5.62 ( 21.47 )	-6.70 ( 99999 )	9.01 ( 15.11 )	-0.30 ( 8.15 )	5.28 ( 17.56 )
Social function	-19.67 ( 15.83 )	-22.30 ( 99999 )	-4.15 ( 8.29 )	-30.53 ( 5.55 )	-16.67 ( 15.17 )
Disease related worries	-8.98 ( 14.63 )	-22.20 ( 99999 )	3.46 ( 16.53 )	-18.05 ( 13.87 )	-7.06 ( 16.37 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From the start of the first study medication (Cycle 1 Day 1) up to 6 months after the last dose of study medication, maximum of 33 months. Adverse events beyond 6 months after the last dose were not presented.

Adverse event reporting additional description

The SAS included all participants who received study medication. Participants who received the therapeutic dose of 177Lu-IPN01072 during the core trial period in Part A and B.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.1

Reporting group title

Part A: 177Lu-IPN01072 4.5 GBq

Reporting group description

Participants received 4.5 GBq 177Lu-IPN01072 (target dose of 300 mcg ±50 mcg) IV infusion on Day 1 of 3 treatment cycles. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AE which had not adequately recovered).

Reporting group title

Part B Cohort 1: 177Lu-IPN01072 6 GBq

Reporting group description

Participants received 6 GBq 177Lu-IPN01072 (target dose of 300 mcg) IV infusion on Day 1 of 3 treatment cycles. The radioactivity dose was reduced to 4.5 GBq in Cohort 1 adapted as recommended by DRB. As a result, Cohort 1 adapted was similar to Cohort 1 except the radioactivity dose was 4.5 GBq. Each cycle was 8 weeks apart (+2 weeks or up to +4 weeks in case of AEs which had not adequately recovered).

Reporting group title

Part B Cohort 3: 177Lu-IPN01072 4.5 GBq

Reporting group description

Reporting group title

Part B Cohort 6: 177Lu-IPN01072 4.5 GBq

Reporting group description

Reporting group title

All Participants

Reporting group description

Serious adverse events	Part A: 177Lu-IPN01072 4.5 GBq	Part B Cohort 1: 177Lu-IPN01072 6 GBq	Part B Cohort 3: 177Lu-IPN01072 4.5 GBq	Part B Cohort 6: 177Lu-IPN01072 4.5 GBq	All Participants
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 15 (13.33%)	1 / 6 (16.67%)	2 / 9 (22.22%)	3 / 10 (30.00%)	8 / 40 (20.00%)
number of deaths (all causes)	2	0	0	1	3
number of deaths resulting from adverse events	0	0	0	1	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
Malignant melanoma
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Precursor B-lymphoblastic lymphoma
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Tumour marker increased
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypotension
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Tachycardia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Presyncope
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	3 / 3	0 / 0	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Part A: 177Lu-IPN01072 4.5 GBq	Part B Cohort 1: 177Lu-IPN01072 6 GBq	Part B Cohort 3: 177Lu-IPN01072 4.5 GBq	Part B Cohort 6: 177Lu-IPN01072 4.5 GBq	All Participants
Total subjects affected by non serious adverse events
subjects affected / exposed	15 / 15 (100.00%)	6 / 6 (100.00%)	9 / 9 (100.00%)	9 / 10 (90.00%)	39 / 40 (97.50%)
Vascular disorders
Flushing
subjects affected / exposed	9 / 15 (60.00%)	0 / 6 (0.00%)	2 / 9 (22.22%)	1 / 10 (10.00%)	12 / 40 (30.00%)
occurrences all number	13	0	5	3	21
Hot flush
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	3 / 10 (30.00%)	4 / 40 (10.00%)
occurrences all number	0	0	1	3	4
Hypotension
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	2 / 9 (22.22%)	0 / 10 (0.00%)	3 / 40 (7.50%)
occurrences all number	2	0	5	0	7
Hypertension
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
General disorders and administration site conditions
Asthenia
subjects affected / exposed	3 / 15 (20.00%)	3 / 6 (50.00%)	2 / 9 (22.22%)	5 / 10 (50.00%)	13 / 40 (32.50%)
occurrences all number	3	3	5	11	22
Fatigue
subjects affected / exposed	9 / 15 (60.00%)	0 / 6 (0.00%)	3 / 9 (33.33%)	1 / 10 (10.00%)	13 / 40 (32.50%)
occurrences all number	13	0	6	1	20
Feeling hot
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	2	0	0	0	2
Infusion site reaction
subjects affected / exposed	0 / 15 (0.00%)	2 / 6 (33.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	2	0	0	2
Malaise
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	2 / 10 (20.00%)	2 / 40 (5.00%)
occurrences all number	0	0	0	3	3
Pyrexia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	2 / 9 (22.22%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	1	0	2
Chest discomfort
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	5	0	5
Chest pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Chills
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Discomfort
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Influenza like illness
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Injection site bruising
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Injection site reaction
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Injection site swelling
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Non-cardiac chest pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Oedema peripheral
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Sense of oppression
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Xerosis
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	2	2
Reproductive system and breast disorders
Ovarian cyst
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	2	0	0	1	3
Dyspnoea
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	1	0	3	1	5
Epistaxis
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	2	0	0	0	2
Oropharyngeal pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Wheezing
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	2 / 40 (5.00%)
occurrences all number	1	0	0	1	2
Dyspnoea exertional
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Hiccups
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Lung cyst
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Psychiatric disorders
Insomnia
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Affective disorder
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	1	0	0	1
Depressed mood
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Sleep disorder
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Product issues
Product leakage
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Investigations
Lymphocyte count decreased
subjects affected / exposed	3 / 15 (20.00%)	0 / 6 (0.00%)	4 / 9 (44.44%)	0 / 10 (0.00%)	7 / 40 (17.50%)
occurrences all number	8	0	14	0	22
Platelet count decreased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	4 / 9 (44.44%)	0 / 10 (0.00%)	5 / 40 (12.50%)
occurrences all number	2	0	11	0	13
White blood cell count decreased
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	2 / 9 (22.22%)	0 / 10 (0.00%)	4 / 40 (10.00%)
occurrences all number	5	0	6	0	11
C-reactive protein increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	1	0	2	2	5
Blood urea increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	2	0	1	0	3
Protein urine present
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	4	0	5
White blood cell count increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Albumin urine present
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Blood creatinine increased
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	2	0	2
Blood potassium decreased
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Blood potassium increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	3	0	0	0	3
Blood pressure decreased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Cardiac murmur
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Cortisol decreased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Creatinine renal clearance decreased
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Electrocardiogram QT prolonged
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Electrocardiogram ambulatory abnormal
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Glomerular filtration rate decreased
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	2	0	2
Liver function test increased
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	2	0	0	0	2
Bilirubin urine present
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	2	0	2
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	2 / 15 (13.33%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	3 / 40 (7.50%)
occurrences all number	3	1	0	0	4
Fall
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	2	0	0	0	2
Burn oesophageal
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Contusion
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Muscle strain
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	1	0	0	1
Occupational exposure to radiation
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Cardiac disorders
Tachycardia
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	3	0	0	2	5
Palpitations
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	2 / 40 (5.00%)
occurrences all number	1	0	0	1	2
Supraventricular extrasystoles
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Arrhythmia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Ventricular extrasystoles
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	2 / 40 (5.00%)
occurrences all number	0	0	1	1	2
Nervous system disorders
Headache
subjects affected / exposed	5 / 15 (33.33%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	7 / 40 (17.50%)
occurrences all number	7	0	3	1	11
Dizziness
subjects affected / exposed	4 / 15 (26.67%)	1 / 6 (16.67%)	1 / 9 (11.11%)	0 / 10 (0.00%)	6 / 40 (15.00%)
occurrences all number	5	1	1	0	7
Dysgeusia
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	2 / 9 (22.22%)	1 / 10 (10.00%)	5 / 40 (12.50%)
occurrences all number	4	0	2	3	9
Lethargy
subjects affected / exposed	3 / 15 (20.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	3 / 40 (7.50%)
occurrences all number	8	0	0	0	8
Paraesthesia
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Parosmia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	2 / 9 (22.22%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	0	0	2	0	2
Syncope
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	1	0	0	1
Taste disorder
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	4	0	0	0	4
Hypogeusia
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	2	0	0	0	2
Sensory disturbance
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	3 / 15 (20.00%)	3 / 6 (50.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	8 / 40 (20.00%)
occurrences all number	10	13	4	1	28
Neutropenia
subjects affected / exposed	2 / 15 (13.33%)	2 / 6 (33.33%)	1 / 9 (11.11%)	1 / 10 (10.00%)	6 / 40 (15.00%)
occurrences all number	3	6	1	3	13
Anaemia
subjects affected / exposed	3 / 15 (20.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	5 / 40 (12.50%)
occurrences all number	3	0	1	2	6
Lymphopenia
subjects affected / exposed	1 / 15 (6.67%)	2 / 6 (33.33%)	2 / 9 (22.22%)	0 / 10 (0.00%)	5 / 40 (12.50%)
occurrences all number	1	10	2	0	13
Leukopenia
subjects affected / exposed	2 / 15 (13.33%)	1 / 6 (16.67%)	1 / 9 (11.11%)	0 / 10 (0.00%)	4 / 40 (10.00%)
occurrences all number	2	4	1	0	7
Lymph node pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Myelosuppression
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Ear and labyrinth disorders
Deafness neurosensory
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Deafness unilateral
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
External ear pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Tinnitus
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Vestibular disorder
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Gastrointestinal disorders
Nausea
subjects affected / exposed	12 / 15 (80.00%)	1 / 6 (16.67%)	5 / 9 (55.56%)	8 / 10 (80.00%)	26 / 40 (65.00%)
occurrences all number	24	1	13	15	53
Diarrhoea
subjects affected / exposed	8 / 15 (53.33%)	1 / 6 (16.67%)	6 / 9 (66.67%)	6 / 10 (60.00%)	21 / 40 (52.50%)
occurrences all number	18	1	14	8	41
Vomiting
subjects affected / exposed	5 / 15 (33.33%)	0 / 6 (0.00%)	4 / 9 (44.44%)	6 / 10 (60.00%)	15 / 40 (37.50%)
occurrences all number	8	0	12	9	29
Abdominal pain
subjects affected / exposed	5 / 15 (33.33%)	1 / 6 (16.67%)	1 / 9 (11.11%)	3 / 10 (30.00%)	10 / 40 (25.00%)
occurrences all number	7	1	2	4	14
Abdominal pain upper
subjects affected / exposed	5 / 15 (33.33%)	1 / 6 (16.67%)	0 / 9 (0.00%)	2 / 10 (20.00%)	8 / 40 (20.00%)
occurrences all number	5	1	0	5	11
Constipation
subjects affected / exposed	4 / 15 (26.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	6 / 40 (15.00%)
occurrences all number	4	0	1	1	6
Dyspepsia
subjects affected / exposed	1 / 15 (6.67%)	1 / 6 (16.67%)	0 / 9 (0.00%)	2 / 10 (20.00%)	4 / 40 (10.00%)
occurrences all number	1	1	0	2	4
Flatulence
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	2	0	0	1	3
Gastrointestinal sounds abnormal
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	2	0	0	1	3
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	2 / 10 (20.00%)	3 / 40 (7.50%)
occurrences all number	1	0	0	3	4
Abdominal discomfort
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Abdominal distension
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	2 / 40 (5.00%)
occurrences all number	1	0	0	1	2
Dry mouth
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Stomatitis
subjects affected / exposed	1 / 15 (6.67%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	1	0	0	2
Abdominal pain lower
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Abnormal faeces
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Anorectal discomfort
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Breath odour
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Dental caries
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Epigastric discomfort
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Frequent bowel movements
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Gastrointestinal motility disorder
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	2	0	0	0	2
Gingival bleeding
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Lip dry
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Odynophagia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Paraesthesia oral
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	1	0	0	1
Steatorrhoea
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	2	0	0	0	2
Toothache
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Hepatobiliary disorders
Hepatomegaly
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	3	0	0	0	3
Hepatic pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	9 / 15 (60.00%)	2 / 6 (33.33%)	3 / 9 (33.33%)	5 / 10 (50.00%)	19 / 40 (47.50%)
occurrences all number	14	2	3	5	24
Dry skin
subjects affected / exposed	2 / 15 (13.33%)	1 / 6 (16.67%)	0 / 9 (0.00%)	1 / 10 (10.00%)	4 / 40 (10.00%)
occurrences all number	3	1	0	1	5
Rash
subjects affected / exposed	1 / 15 (6.67%)	1 / 6 (16.67%)	1 / 9 (11.11%)	1 / 10 (10.00%)	4 / 40 (10.00%)
occurrences all number	1	1	2	1	5
Hyperhidrosis
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	2	0	0	1	3
Pruritus
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	3 / 40 (7.50%)
occurrences all number	1	0	1	1	3
Erythema
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Night sweats
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Onychoclasis
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Rash papular
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	1	0	0	1
Urticaria
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Renal and urinary disorders
Microalbuminuria
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	3 / 15 (20.00%)	1 / 6 (16.67%)	2 / 9 (22.22%)	1 / 10 (10.00%)	7 / 40 (17.50%)
occurrences all number	5	1	5	2	13
Back pain
subjects affected / exposed	5 / 15 (33.33%)	0 / 6 (0.00%)	2 / 9 (22.22%)	0 / 10 (0.00%)	7 / 40 (17.50%)
occurrences all number	6	0	3	0	9
Musculoskeletal chest pain
subjects affected / exposed	2 / 15 (13.33%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	3 / 40 (7.50%)
occurrences all number	2	1	0	0	3
Arthritis
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	2	0	0	0	2
Groin pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Musculoskeletal pain
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	4	0	0	0	4
Pain in extremity
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	0	1	0	2
Bone pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	3	0	0	0	3
Coccydynia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	2	0	2
Intervertebral disc protrusion
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Musculoskeletal stiffness
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	2	0	0	0	2
Myalgia
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	4	4
Spinal pain
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	3 / 15 (20.00%)	1 / 6 (16.67%)	2 / 9 (22.22%)	1 / 10 (10.00%)	7 / 40 (17.50%)
occurrences all number	3	1	2	1	7
Bronchitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	2 / 10 (20.00%)	2 / 40 (5.00%)
occurrences all number	0	0	0	2	2
Gastroenteritis
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	2 / 40 (5.00%)
occurrences all number	1	0	0	1	2
Sinusitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	2 / 10 (20.00%)	2 / 40 (5.00%)
occurrences all number	0	0	0	2	2
Upper respiratory tract infection
subjects affected / exposed	1 / 15 (6.67%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	2 / 40 (5.00%)
occurrences all number	1	1	0	0	2
Anal fungal infection
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Conjunctivitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Cystitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Groin abscess
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	0	1	0	1
Perineal infection
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Pharyngitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 40 (2.50%)
occurrences all number	0	0	0	1	1
Tooth abscess
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Tooth infection
subjects affected / exposed	0 / 15 (0.00%)	1 / 6 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	0	1	0	0	1
Viral upper respiratory tract infection
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	2 / 15 (13.33%)	0 / 6 (0.00%)	0 / 9 (0.00%)	3 / 10 (30.00%)	5 / 40 (12.50%)
occurrences all number	3	0	0	3	6
Hyperglycaemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	2 / 40 (5.00%)
occurrences all number	1	0	0	1	2
Increased appetite
subjects affected / exposed	1 / 15 (6.67%)	0 / 6 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 40 (2.50%)
occurrences all number	1	0	0	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

16 Oct 2015

The protocol was amended to address feedback from different authorities and ethics committees. The protocol was also adapted according to standard procedures of the new owner, IPSEN Pharma. Changes included clarifications to inclusion and exclusion, adaptation of the activity escalation scheme to allow greater freedom to the Safety Review Board, removal of an exploratory evaluation of the somatostatin receptor scan, addition of computed tomography/magnetic resonance imaging at Week 12 after the first peptide receptor radionuclide therapy cycle, shifting the EOCT Visit from Week 28 to Week 24 and a number of administrative changes.

02 Dec 2015

The protocol was amended since the initially selected CRO Syneed Medidata was replaced as it entered an insolvency procedure and the sponsor did not want to take the risk of its bankruptcy during the conduct of the trial. The responsibility for pharmacovigilance and safety reporting was assumed by the sponsor leading to changes which were administrative in nature.

11 Dec 2015

The protocol was amended to specify that specific tumour and pituitary markers will be analysed in a central laboratory since some clinical sites do not have all these assessments in the repertoire of the local laboratory.

29 Apr 2016

The protocol was amended to consistently state that in the event of pregnancy the participant ‘will’ be withdrawn from treatment.

04 Oct 2016

The study population was updated. Exploratory objectives added. Several additional safety measures were included. Changes updated to figure 8, 9, 10 and 11. Changes updated to Table 5. Change in sponsor name, study administration section, sponsor approval signatory page and minor typographical changes for consistency throughout the protocol.

03 Nov 2017

Sponsor name updated, project coordinator and sponsor representative name corrected. Editorial changes applied. Extended screening period from 3 to 4 weeks. Confirmed the targeted radioactivity, confirmed that serum pregnancy test was to be done at Screening visit only. Clarification about pituitary markers. Entry criteria clarified. All changes listed above did not interfere with primary endpoint of the study and were done for clarification and to facilitate the recruitment and logistics for the participants and centers.

27 Feb 2018

Editorial changes made in order to put the protocol into the Ipsen template. Peptide mass dose escalation was added to Part B of the study with a design in two cohorts to evaluate if somatostatin receptor subtype 2 receptor saturation is occurring. The design in these two cohorts is a test-retest of increasing peptide at the second cycle to evaluate if receptor saturation is occurring. To carry out additional dose escalation of both peptide mass and radioactivity, eight cohorts have been developed with a step wise increase of peptide mass and radioactivity. The total number of participants in Part B increased. For Part B: Inclusion criteria modified and an exclusion criterion added; Additional changes applied to all participants from the time of implementation. Assessment of urine PK of IPN01072; Evaluation of systemic immune response and circulating markers added; Additional computed tomography (CT)/ magnetic resonance imaging and single-photon emission CT/CT scans added; Dosimetry assessments performed in additional cycles; Rules for delayed administration and treatment withdrawal changed; The list of conditions which were resolved was expanded. Change in tumor volume assessment added. Assessment of deoxyribonucleic acid double strand breaks in lymphocytes and tumour growth rate were removed. Tumour markers and PK parameters assessed were specified. The infusion rates and duration were revised. The volume of blood taken overall were updated. The urine collection time for dosimetric measurements were updated. Schedule of biopsy material collection specified. Details on action taken in case of spillage of investigational radiopharmaceutical product added. Participant withdrawal criteria specified. AE criteria specified. The introduction and study objectives updated.

24 Jul 2018

The protocol was amended to update the screening criteria (refining the inclusion and exclusion criteria) and contact details for the pharmacovigilance and coordinating investigator, to add precautions for handling radioactive material, to add a new assessment day (around Day 42) at which haematology and biochemistry were to be assessed and to make clarifications and corrections for consistency. Changes to clarify the interruption of somatostatin analogue therapy and criteria and safety monitoring that must be met for administering additional cycle were requested by the Food and Drug Administration.

07 May 2019

The protocol was amended to update personnel (sponsor’s representative and signatory), the infusion time/rate and other infusion-related procedures, to amend various assessments timings and clarify inclusion in the additional optional cycles, to amend dose escalation rules in case of toxicity, to specify urine sample collections in US and Canada sites, to amend AE/SAE reporting requirements, including in cases of laboratory abnormalities, to add definition and procedures for adverse event of special interest, to correct minor errors and make other clarifications.

13 Aug 2019

The protocol was amended to update the planned study period, to add an exploratory objective and endpoints to determine therapeutic efficacy using the modified RECIST , to clarify secondary endpoint related to tumour response, to clarify aspects related to the additional cycles (4 and 5) and amend their image reading to be done by a central laboratory, to define DLT definition in Part B, to clarify reporting procedures in “special situation” events, to clarify the decision process for administration of the additional cycles, to add AE reporting for IPN60070, to amend timing of assessments in Part B, to add screened participants population, to add interim analyses such that a total of three were to be performed and aid with cohort initiation decision, to correct minor errors and make other clarifications.

10 Aug 2020

The protocol was amended to clarify the 2-year long-term follow-up period. To add details of the option for participants to take part in a safety surveillance study after the long-term follow-up period is completed. To add an analysis of the 177Lu-IPN01072 dosimetry results according to the formula of the amino-acid solution administrated. To align the tumour response secondary endpoints (ORR, BOR, and DCR) with the statistical analysis plan. To change the secondary objective and secondary endpoint of changes in tumour volume to an exploratory objective and exploratory endpoint. To add DoR as an exploratory endpoint to further characterize the tumour response. To clarify the study populations (Safety Analysis set and ITT set) for analysis. To clarify the timing of the interim analyses and the clinical study report preparation. To clarify about coronavirus disease 2019 following the recent pandemic. To remove reference to the master protocol on the title page as, due to a change in the development strategy, the master protocol Ipsen 001 Version 1.0 has been closed. To align the synopsis and main body of the protocol for consistency. To correct minor errors and make other clarifications.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Due to strategic reasons, the Ipsen management team decided to early terminate the D-FR-01072-001 / OPS-C-001 study. This decision was not due to any safety or tolerability concern, or any event associated with the use of the study drug.

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Clinical trials

Clinical Trial Results: An international multi-center, open-label study to evaluate safety, tolerability, biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201 for the therapy of somatostatin receptor positive neuroendocrine tumours (NETs).

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

Primary: Number of Participants With Dose Limiting Toxicities (DLT)

Primary: Number of Participants With Dose Limiting Toxicities (DLT)

Secondary: Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1

Secondary: Maximum Uptake (%) of 177Lu-IPN01072 at Target Lesions and Discernible Organs in Cycle 1

Secondary: Maximal Uptake (%) of 177Lu-IPN01072 of Blood in Cycle 1

Secondary: Maximal Uptake (%) of 177Lu-IPN01072 of Blood in Cycle 1

Secondary: Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1

Secondary: Area Under the Concentration Time Curve (AUC) of 177Lu-IPN01072 in Discernible Organs in Cycle 1

Secondary: AUC of 177Lu-IPN01072 in Blood in Cycle 1

Secondary: AUC of 177Lu-IPN01072 in Blood in Cycle 1

Secondary: Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1

Secondary: Terminal Half-Life (T1/2) of Radioactivity Concentrations of the Radiopharmaceutical in Blood in Cycle 1

Secondary: Highest Absorbed Dose of 177LU-OPS201 to Each Discernible Organ in Cycle 1

Secondary: Highest Absorbed Dose of 177LU-OPS201 to Each Discernible Organ in Cycle 1

Secondary: Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1

Secondary: Specific Absorbed Dose Per Organ and Lesions of 177Lu-IPN01072 in Cycle 1

Secondary: Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

Secondary: Cumulative Absorbed Organ Doses of 177Lu-IPN01072 in Cycles 1 and 3

Secondary: Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1

Secondary: Cumulative Amount of Lu-177 Radioactivity Excreted Into the Urine (0 to 48 Hours) [Ae (0-48h)] in Cycle 1

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1

Secondary: Time to Reach Maximum Plasma Concentration (Tmax) of IPN01072 in Cycle 1

Secondary: Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1

Secondary: Maximum Observed Plasma Concentration (Cmax) of IPN01072 in Cycle 1

Secondary: AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1

Secondary: AUC From Time Zero to Infinity (AUCinf) of IPN01072 in Cycle 1

Secondary: T1/2 of IPN01072 in Cycle 1

Secondary: T1/2 of IPN01072 in Cycle 1

Secondary: Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1

Secondary: Apparent Total Plasma Clearance of IPN01072 (Total CL) in Cycle 1

Secondary: Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1

Secondary: Apparent Volume of Distribution During Terminal Phase (Vz) of IPN01072 in Cycle 1

Secondary: Ae (0-48h) of IPN01072 in Cycle 1

Secondary: Ae (0-48h) of IPN01072 in Cycle 1

Secondary: Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1

Secondary: Fraction of IPN01072 Excreted Into the Urine (Fe) in Cycle 1

Secondary: Overall Response Rate (ORR)

Secondary: Overall Response Rate (ORR)

Secondary: Disease Control Rate (DCR)

Secondary: Disease Control Rate (DCR)

Secondary: Best Overall Response

Secondary: Best Overall Response

Secondary: Progression Free Survival (PFS)

Secondary: Progression Free Survival (PFS)

Secondary: Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit

Secondary: Change From Baseline in Quality of Life (QoL) Questionnaire (QLQ)-C30 at EOCT Visit

Secondary: Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit

Secondary: Change From Baseline in QLQ Gastro-intestinal. Neuroendocrine Tumour (GI.NET)21 at EOCT Visit

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
An international multi-center, open-label study to evaluate safety, tolerability, biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201 for the therapy of somatostatin receptor positive neuroendocrine tumours (NETs).