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    Clinical Trial Results:
    A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinoma

    Summary
    EudraCT number
    		 2020-005767-31
    Trial protocol
    		 ES  
    Global end of trial date
    25 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2025
    First version publication date
    20 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M20-732
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04807972
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    AbbVie, Global Medical Services, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    AbbVie, Global Medical Services, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Phase 1b: The primary objective for the Phase 1b part of the study is to assess the safety and tolerability of mFFX combined with ABBV-927 and budigalimab in subjects with previously untreated metastatic pancreatic adenocarcinoma. Phase 2: The primary objective for the Phase 2 part of the study is to assess the effect on overall survival of mFFX combined with ABBV-927 with or without budigalimab compared to mFFX alone in subjects with treatment-naïve metastatic pancreatic adenocarcinoma.
    Protection of trial subjects
    Prior to any study-related screening procedures being performed on the subject or any medications being discontinued by the subject in order to participate in this study, the informed consent statement will be reviewed, signed, and dated by the subject or their legally authorized representative, the person who administered the informed consent, and any other signatories according to local requirements. A copy of the signed informed consent will be given to the subject and the original will be placed in the subject's medical record.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 May 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Puerto Rico: 1
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United States: 13
    Worldwide total number of subjects
    28
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    17
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 28 subjects were enrolled in the dose escalation phase (Phase 1b) of the study (N=9 in Cohort 1 and N=19 in Cohort 2). The sponsor closed the study for business not safety reasons. At the time of notification to close, active subjects remained in Cohort 2 of the Phase 1b dose escalation, and enrollment in Phase 2 was not initiated.

    Period 1
    Period 1 title
    Phase 1b Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg
    Arm description
    		 Dose escalation stage: ABBV-927 was administered via IV infusion Q4W at dose of 0.1 mg/kg. Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-927
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    ABBV-927 was administered via IV infusion Q4W at dose of 0.1 mg/kg. Each treatment cycle was 28 days. ABBV-927 and budigalimab were administered on Day 3 of each cycle. For the mFFX components, oxaliplatin, leucovorin, and irinotecan were administered on Days 1 and 15 of each cycle and 5-fluorouracil was administered on Days 1, 3 and 15, 17 of each cycle. Subjects were treated until radiographic disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, unacceptable toxicity, or other withdrawal/discontinuation criteria were fulfilled.

    Investigational medicinal product name
    Budigalimab
    Investigational medicinal product code
    Other name
    ABBV-181
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg. Each treatment cycle was 28 days. ABBV-927 and budigalimab were administered on Day 3 of each cycle. For the mFFX components, oxaliplatin, leucovorin, and irinotecan were administered on Days 1 and 15 of each cycle and 5-fluorouracil was administered on Days 1, 3 and 15, 17 of each cycle. Subjects were treated until radiographic disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, unacceptable toxicity, or other withdrawal/discontinuation criteria were fulfilled.

    Investigational medicinal product name
    modified FOLFIRINOX
    Investigational medicinal product code
    Other name
    mFFX
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Each treatment cycle was 28 days. ABBV-927 and budigalimab were administered on Day 3 of each cycle. For the mFFX components, oxaliplatin, leucovorin, and irinotecan were administered on Days 1 and 15 of each cycle and 5-fluorouracil was administered on Days 1, 3 and 15, 17 of each cycle. Subjects were treated until radiographic disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, unacceptable toxicity, or other withdrawal/discontinuation criteria were fulfilled.

    Arm title
    		 mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Arm description
    		 Dose escalation stage: ABBV-927 was administered via IV infusion Q4W at dose of 0.3 mg/kg. Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-927
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    ABBV-927 was administered via IV infusion Q4W at dose of 0.3 mg/kg. Each treatment cycle was 28 days. ABBV-927 and budigalimab were administered on Day 3 of each cycle. For the mFFX components, oxaliplatin, leucovorin, and irinotecan were administered on Days 1 and 15 of each cycle and 5-fluorouracil was administered on Days 1, 3 and 15, 17 of each cycle. Subjects were treated until radiographic disease progression per (Response Evaluation Criteria in Solid Tumors) RECIST v1.1, unacceptable toxicity, or other withdrawal/discontinuation criteria were fulfilled.

    Investigational medicinal product name
    Budigalimab
    Investigational medicinal product code
    Other name
    ABBV-181
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg. Each treatment cycle was 28 days. ABBV-927 and budigalimab were administered on Day 3 of each cycle. For the mFFX components, oxaliplatin, leucovorin, and irinotecan were administered on Days 1 and 15 of each cycle and 5-fluorouracil was administered on Days 1, 3 and 15, 17 of each cycle. Subjects were treated until radiographic disease progression per (Response Evaluation Criteria in Solid Tumors) RECIST v1.1, unacceptable toxicity, or other withdrawal/discontinuation criteria were fulfilled.

    Investigational medicinal product name
    modified FOLFIRINOX
    Investigational medicinal product code
    Other name
    mFFX
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Each treatment cycle was 28 days. ABBV-927 and budigalimab were administered on Day 3 of each cycle. For the mFFX components, oxaliplatin, leucovorin, and irinotecan were administered on Days 1 and 15 of each cycle and 5-fluorouracil was administered on Days 1, 3 and 15, 17 of each cycle. Subjects were treated until radiographic disease progression per (Response Evaluation Criteria in Solid Tumors) RECIST v1.1, unacceptable toxicity, or other withdrawal/discontinuation criteria were fulfilled.

    Number of subjects in period 1
    		mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Started
    9
    19
    Completed
    0
    0
    Not completed
    9
    19
         Adverse event, non-fatal
    -
    1
         Other
    1
    1
         No longer clinically benefiting
    1
    -
         Progressive disease
    7
    12
         Withdrawal by subject
    -
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg
    Reporting group description
    		 Dose escalation stage: ABBV-927 was administered via IV infusion Q4W at dose of 0.1 mg/kg. Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg.

    Reporting group title
    mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Reporting group description
    		 Dose escalation stage: ABBV-927 was administered via IV infusion Q4W at dose of 0.3 mg/kg. Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg.

    Reporting group values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg Total
    Number of subjects
    		 9 19 28
    Age categorical
    Units: Subjects
        < 40 years
    		 0 1 1
        40 - 64 years
    		 4 12 16
        ≥ 65 years
    		 5 6 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.7 ( 4.53 ) 60.1 ( 10.27 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 9 13
        Male
    		 5 10 15

    End points

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    End points reporting groups
    Reporting group title
    mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg
    Reporting group description
    		 Dose escalation stage: ABBV-927 was administered via IV infusion Q4W at dose of 0.1 mg/kg. Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg.

    Reporting group title
    mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Reporting group description
    		 Dose escalation stage: ABBV-927 was administered via IV infusion Q4W at dose of 0.3 mg/kg. Budigalimab (ABBV-181) was administered as an IV infusion Q4W at a dose of 500 mg.

    Primary: Phase 1b: Percentage of participants experiencing Adverse Events

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    End point title
    		 Phase 1b: Percentage of participants experiencing Adverse Events [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
    End point type
    Primary
    End point timeframe
    Up to 6 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: There will be no statistical testing for all of the efficacy and safety endpoints.
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    9
    19
    Units: percentage of participants
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    Primary: Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values

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    End point title
    		 Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values [2]
    End point description
    Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for laboratory data as applicable. If more than one measurement exists for a participant on a particular day and time, an arithmetic average will be calculated. This average will be that participant's measurement for that day. For participants that do not have any post-baseline measurements, only their baseline values will be summarized.
    End point type
    Primary
    End point timeframe
    Up to 6 months
    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: There will be no statistical testing for all of the efficacy and safety endpoints.
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: participants
    Notes
    [3] - Laboratory values over time were not summarized due to this study being terminated early.
    [4] - Laboratory values over time were not summarized due to this study being terminated early.
    No statistical analyses for this end point

    Primary: Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs

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    End point title
    		 Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs [5]
    End point description
    Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.
    End point type
    Primary
    End point timeframe
    Up to 6 months
    Notes
    [5] - 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: There will be no statistical testing for all of the efficacy and safety endpoints.
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    9 [6]
    18 [7]
    Units: participants
        Diastolic Blood Pressure < 50 & ≥ 20 mmHg Decrease
    0
    0
        Diastolic Blood Pressure > 100 & > 0 mmHg Increase
    0
    0
        Pulse Rate < 50 & ≥ 30 beats/min Decrease
    0
    1
        Pulse Rate > 120 & ≥ 30 beats/min Increase
    0
    1
        Systolic Blood Pressure < 70 & ≥ 30 mmHg Decrease
    0
    0
        Systolic Blood Pressure > 160 & > 0 mmHg Increase
    1
    2
        Temperature ≤ 35.6 ◦C
    4
    7
        Temperature ≥ 38.8 ◦C
    0
    1
    Notes
    [6] - Denominator indicates the number of subjects with non-missing baseline and post baseline values.
    [7] - Denominator indicates the number of subjects with non-missing baseline and post baseline values.
    No statistical analyses for this end point

    Primary: Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)

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    End point title
    		 Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT) [8]
    End point description
    A DLT is defined as any serious AE for which a clear alternative cause cannot be established (e.g., attributed to the disease under study, another disease, or to a concomitant medication [e.g., COVID-19 vaccine] by the investigator or AbbVie Therapeutic Area (TA) MD] that occurs during the DLT observation period, and is not listed as a predefined exception in the protocol.
    End point type
    Primary
    End point timeframe
    Up to 6 months
    Notes
    [8] - 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: There will be no statistical testing for all of the efficacy and safety endpoints.
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    9
    19
    Units: participants
    1
    1
    No statistical analyses for this end point

    Secondary: Phase 1b: Maximum Plasma Concentration (Cmax)

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    End point title
    		 Phase 1b: Maximum Plasma Concentration (Cmax)
    End point description
    The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
    End point type
    Secondary
    End point timeframe
    Up to approximately 3 months
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    7
    15
    Units: µg/mL
        geometric mean (geometric coefficient of variation)
    0.692 ( 51 )
    5.36 ( 58 )
    No statistical analyses for this end point

    Secondary: Phase 1b: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the Patient Global Impression of Change (PGIC)

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    End point title
    		 Phase 1b: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the Patient Global Impression of Change (PGIC)
    End point description
    Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) will measure participants' overall perceptions of their pancreatic cancer symptoms over time.
    End point type
    Secondary
    End point timeframe
    Up to approximately 25 months
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: participants
    Notes
    [9] - Data were not collected for this Outcome Measure due to early termination of the study.
    [10] - Data were not collected for this Outcome Measure due to early termination of the study.
    No statistical analyses for this end point

    Secondary: Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma

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    End point title
    		 Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
    End point description
    The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
    End point type
    Secondary
    End point timeframe
    Up to approximately 3 months.
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    7 [11]
    15 [12]
    Units: µg*h/mL
        geometric mean (geometric coefficient of variation)
    84.2 ( 43 )
    421 ( 34 )
    Notes
    [11] - AUC336 is reported; N=4
    [12] - AUC336 is reported; N=7
    No statistical analyses for this end point

    Secondary: Phase 1b: Objective Response Rate (ORR)

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    End point title
    		 Phase 1b: Objective Response Rate (ORR)
    End point description
    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    End point type
    Secondary
    End point timeframe
    Up to approximately 27 months
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    9 [13]
    19 [14]
    Units: percentage of participants
        number (confidence interval 95%)
    22.2 (2.8 to 60.0)
    21.1 (6.1 to 45.6)
    Notes
    [13] - 95% confidence interval is from the exact binomial distribution
    [14] - 95% confidence interval is from the exact binomial distribution
    No statistical analyses for this end point

    Secondary: Phase 1b: Clinical Benefit Rate (CBR)

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    End point title
    		 Phase 1b: Clinical Benefit Rate (CBR)
    End point description
    Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response is either Complete Response (CR), Partial Response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. For stable disease to be considered clinical benefit it must last for at least 28 weeks.
    End point type
    Secondary
    End point timeframe
    Up to approximately 27 months
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    9 [15]
    19 [16]
    Units: percentage of participants
        number (confidence interval 95%)
    22.2 (2.8 to 60.0)
    31.6 (12.6 to 56.6)
    Notes
    [15] - 95% confidence interval is from the exact binomial distribution
    [16] - 95% confidence interval is from the exact binomial distribution
    No statistical analyses for this end point

    Secondary: Phase 1b: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR

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    End point title
    		 Phase 1b: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
    End point description
    DOR is defined as the time from the initial response of CR/PR per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first. "99999" indicates non-estimable.
    End point type
    Secondary
    End point timeframe
    Up to approximately 27 months
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    9
    19
    Units: months
        median (confidence interval 95%)
    15.2 (12.39 to 99999)
    7.5 (4.17 to 99999)
    No statistical analyses for this end point

    Secondary: Phase 1b: Progression Free Survival (PFS)

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    End point title
    		 Phase 1b: Progression Free Survival (PFS)
    End point description
    PFS is defined as the time from randomization to a documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, clinical progression or death from any cause, whichever occurs earlier.
    End point type
    Secondary
    End point timeframe
    Up to approximately 24 months after study drug discontinuation
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    9
    19
    Units: months
        median (confidence interval 95%)
    5.8 (1.81 to 13.96)
    7.4 (3.12 to 9.43)
    No statistical analyses for this end point

    Secondary: Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)

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    End point title
    		 Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)
    End point description
    The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax.
    End point type
    Secondary
    End point timeframe
    Up to approximately 3 months
    End point values
    		 mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg
    Number of subjects analysed
    7
    15
    Units: hours
        median (full range (min-max))
    1.75 (1.75 to 3.5)
    1.75 (1.75 to 5.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality were reported from enrollment to study termination, median time on follow-up was 24.7 months for Cohort 1 (mFFX + ABBV-927 0.1 mg/kg + budigalimab 500 mg) and 16.6 months for Cohort 2 (mFFX + ABBV-927 0.3 mg/kg + budigalimab 500 mg).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    mFFX_ABBV-927_0.1_mg_kg_budigalimab-Dose_Escalation
    Reporting group description
    		 -

    Reporting group title
    mFFX_ABBV-927_0.3_mg_kg_budigalimab-Dose_Escalation
    Reporting group description
    		 -

    Serious adverse events
    		 mFFX_ABBV-927_0.1_mg_kg_budigalimab-Dose_Escalation mFFX_ABBV-927_0.3_mg_kg_budigalimab-Dose_Escalation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 9 (88.89%)
    12 / 19 (63.16%)
         number of deaths (all causes)
    7
    13
         number of deaths resulting from adverse events
    1
    4
    Investigations
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    MALAISE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FATIGUE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DISEASE PROGRESSION
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    PYREXIA
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUDDEN DEATH
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    CYTOKINE RELEASE SYNDROME
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTERITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS ACUTE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    IMMUNE-MEDIATED HEPATITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PLEURAL EFFUSION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOXIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    BACTERAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL BACTERAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIC SEPSIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    HEPATOBILIARY INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA INFECTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPIGLOTTITIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOCCAL INFECTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS INTESTINAL PERFORATED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CATHETER SITE INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM DIFFICILE COLITIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 PNEUMONIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DECREASED APPETITE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 mFFX_ABBV-927_0.1_mg_kg_budigalimab-Dose_Escalation mFFX_ABBV-927_0.3_mg_kg_budigalimab-Dose_Escalation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    19 / 19 (100.00%)
    Vascular disorders
    HYPOTENSION
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    HYPERTENSION
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    FLUSHING
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    5 / 9 (55.56%)
    5 / 19 (26.32%)
         occurrences all number
    11
    9
    CATHETER SITE SWELLING
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    FATIGUE
         subjects affected / exposed
    3 / 9 (33.33%)
    9 / 19 (47.37%)
         occurrences all number
    8
    15
    FEELING HOT
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HYPOTHERMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    MALAISE
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    MUCOSAL INFLAMMATION
         subjects affected / exposed
    4 / 9 (44.44%)
    2 / 19 (10.53%)
         occurrences all number
    6
    4
    OEDEMA PERIPHERAL
         subjects affected / exposed
    4 / 9 (44.44%)
    3 / 19 (15.79%)
         occurrences all number
    4
    4
    PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    PYREXIA
         subjects affected / exposed
    3 / 9 (33.33%)
    6 / 19 (31.58%)
         occurrences all number
    4
    8
    TEMPERATURE INTOLERANCE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    3
    Reproductive system and breast disorders
    PELVIC PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    RHINORRHOEA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    PULMONARY EMBOLISM
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    PNEUMOTHORAX
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    PNEUMONITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    PLEURAL EFFUSION
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    NASAL PRURITUS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    NASAL CONGESTION
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    INTRANASAL HYPOAESTHESIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    COUGH
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 19 (0.00%)
         occurrences all number
    5
    0
    DYSPHONIA
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    EPISTAXIS
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    5
    HICCUPS
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    4
    DEPRESSION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    ANXIETY
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Investigations
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    AMYLASE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    BLOOD ALKALINE PHOSPHATASE INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    BLOOD BICARBONATE DECREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    BLOOD LACTATE DEHYDROGENASE INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    GAMMA-GLUTAMYLTRANSFERASE DECREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    8
    HEART RATE IRREGULAR
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    3
    LIPASE INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    LYMPHOCYTE COUNT DECREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 19 (15.79%)
         occurrences all number
    2
    7
    PANCREATIC ENZYMES INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    1
    3
    RETICULOCYTE COUNT INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    URINARY CASTS PRESENT
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    WEIGHT DECREASED
         subjects affected / exposed
    2 / 9 (22.22%)
    8 / 19 (42.11%)
         occurrences all number
    3
    12
    WHITE BLOOD CELL COUNT DECREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    WHITE BLOOD CELL COUNT INCREASED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    INFUSION RELATED REACTION
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 19 (21.05%)
         occurrences all number
    0
    4
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    SEROMA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    WOUND DEHISCENCE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    VENTRICULAR TACHYCARDIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    PERIPHERAL SENSORY NEUROPATHY
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 19 (21.05%)
         occurrences all number
    0
    7
    BALANCE DISORDER
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    CHOLINERGIC SYNDROME
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    COLD DYSAESTHESIA
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 19 (15.79%)
         occurrences all number
    1
    3
    DIZZINESS
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    1
    3
    DYSAESTHESIA
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 19 (15.79%)
         occurrences all number
    4
    3
    DYSARTHRIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    DYSGEUSIA
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 19 (26.32%)
         occurrences all number
    2
    8
    HEADACHE
         subjects affected / exposed
    2 / 9 (22.22%)
    4 / 19 (21.05%)
         occurrences all number
    2
    4
    HYPOAESTHESIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    5 / 9 (55.56%)
    4 / 19 (21.05%)
         occurrences all number
    11
    7
    NEUROTOXICITY
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    4
    PARAESTHESIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    TREMOR
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    4 / 9 (44.44%)
    5 / 19 (26.32%)
         occurrences all number
    8
    9
    ANAEMIA MACROCYTIC
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HEPARIN-INDUCED THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    LEUKOCYTOSIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    NEUTROPENIA
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 19 (15.79%)
         occurrences all number
    1
    7
    THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    7
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Eye disorders
    CATARACT
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    VISION BLURRED
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    DRY EYE
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    LACRIMATION INCREASED
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    PHOTOPHOBIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    CONJUNCTIVAL HYPERAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    VITREOUS FLOATERS
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    HYPOAESTHESIA ORAL
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    2
    ABDOMINAL PAIN
         subjects affected / exposed
    4 / 9 (44.44%)
    3 / 19 (15.79%)
         occurrences all number
    4
    6
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 19 (15.79%)
         occurrences all number
    3
    3
    COLITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    CONSTIPATION
         subjects affected / exposed
    3 / 9 (33.33%)
    7 / 19 (36.84%)
         occurrences all number
    4
    9
    DEFAECATION URGENCY
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    DIARRHOEA
         subjects affected / exposed
    4 / 9 (44.44%)
    11 / 19 (57.89%)
         occurrences all number
    13
    25
    DRY MOUTH
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    DYSPEPSIA
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    FAECES DISCOLOURED
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    FAECES SOFT
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    FLATULENCE
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 19 (15.79%)
         occurrences all number
    2
    3
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    HAEMORRHOIDAL HAEMORRHAGE
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    HAEMORRHOIDS
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    ILEUS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    LIP DRY
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    NAUSEA
         subjects affected / exposed
    7 / 9 (77.78%)
    10 / 19 (52.63%)
         occurrences all number
    16
    13
    ORAL DYSAESTHESIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    PANCREATIC FAILURE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    PARAESTHESIA ORAL
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    STEATORRHOEA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    STOMATITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    VOMITING
         subjects affected / exposed
    3 / 9 (33.33%)
    8 / 19 (42.11%)
         occurrences all number
    4
    13
    LARGE INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    JAUNDICE
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    CHOLANGITIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HYPERTRANSAMINASAEMIA
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    PORTAL VEIN THROMBOSIS
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    ERYTHEMA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    DRY SKIN
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    DECUBITUS ULCER
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    COLD SWEAT
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    SKIN DISCOLOURATION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    SERPENTINE SUPRAVENOUS HYPERPIGMENTATION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    RASH PRURITIC
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    RASH
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    PRURITUS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HYPERHIDROSIS
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    SKIN ULCER
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    SKIN HYPERPIGMENTATION
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    NIGHT SWEATS
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    STERILE PYURIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    PROTEINURIA
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    FLANK PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    BACK PAIN
         subjects affected / exposed
    1 / 9 (11.11%)
    5 / 19 (26.32%)
         occurrences all number
    2
    7
    ARTHRALGIA
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    2
    2
    GROIN PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    MUSCLE SPASMS
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    MUSCULAR WEAKNESS
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    2
    PAIN IN JAW
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    BONE PAIN
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    CLOSTRIDIUM DIFFICILE INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    GENITAL CANDIDIASIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HERPES SIMPLEX REACTIVATION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    OROPHARYNGEAL CANDIDIASIS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    PNEUMONIA
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    RASH PUSTULAR
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    SKIN CANDIDA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    VAGINAL INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    VULVOVAGINAL MYCOTIC INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    CANDIDA INFECTION
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    5 / 9 (55.56%)
    6 / 19 (31.58%)
         occurrences all number
    8
    8
    DEHYDRATION
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HYPERKALAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    HYPOALBUMINAEMIA
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1
    HYPOCALCAEMIA
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    HYPOGLYCAEMIA
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    HYPOKALAEMIA
         subjects affected / exposed
    3 / 9 (33.33%)
    5 / 19 (26.32%)
         occurrences all number
    4
    8
    HYPOMAGNESAEMIA
         subjects affected / exposed
    3 / 9 (33.33%)
    4 / 19 (21.05%)
         occurrences all number
    3
    7
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    HYPONATRAEMIA
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 19 (10.53%)
         occurrences all number
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Feb 2021
    Version 2.0, Global Amendment updated eligibility criteria, time requirements for prohibited medications, toxicity management, DLT criteria and statistical analyses.
    25 May 2021
    Version 3.0, Global Amendment updated DLT criteria.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Jul 2023
    The sponsor closed the study for business reasons and not for safety reasons. At the time of notification to close, active subjects remained in Cohort 2 of the Phase 1b dose escalation, and enrollment in Phase 2 was not initiated. All subjects, regardless of reason for discontinuation of study treatment, underwent a final study visit and were followed for progression and survival.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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