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    Clinical Trial Results:
    A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma

    Summary
    EudraCT number
    		 2022-002169-14
    Trial protocol
    		 HU   ES  
    Global end of trial date
    22 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2025
    First version publication date
    11 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAK-573-2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05590377
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    95 Hayden Avenue, Lexington, Massachusetts, United States, 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.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
    22 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to determine the safety and tolerability of modakafusp alfa in combination with daratumumab subcutaneous (SC) in Phase 1 Dose Escalation.
    Protection of trial subjects
    Each participant signed an informed consent form (ICF) before participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    23 Jan 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Worldwide total number of subjects
    15
    EEA total number of subjects
    4
    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)
    8
    From 65 to 84 years
    6
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 9 investigative sites globally from 23 January 2023 to 22 May 2024.

    Pre-assignment
    Screening details
    		 Participants with multiple myeloma were enrolled in Phase 1 (Dose Escalation) to receive modakafusp alfa (80 milligrams [mg], 120 mg or 240 mg) + daratumumab. No participants were enrolled in Phase 2a (Dose Finding) as the study was terminated by the Sponsor due to strategic reasons.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
    Arm description
    		 Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Darzalex
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

    Investigational medicinal product name
    Modakafusp Alfa
    Investigational medicinal product code
    TAK-573
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Modakafusp alfa 80 mg, IV once Q4W in each 28-day treatment cycle until disease progression.

    Arm title
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
    Arm description
    		 Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Darzalex
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

    Investigational medicinal product name
    Modakafusp Alfa
    Investigational medicinal product code
    TAK-573
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Modakafusp alfa 120 mg, IV, Q4W in each 28-day treatment cycle until disease progression.

    Arm title
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Arm description
    		 Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Darzalex
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

    Investigational medicinal product name
    Modakafusp Alfa
    Investigational medicinal product code
    TAK-573
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Modakafusp alfa 240 mg, infusion, IV, Q4W in each 28-day treatment cycle until disease progression.

    Number of subjects in period 1
    		Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Started
    3
    6
    6
    Completed
    0
    0
    0
    Not completed
    3
    6
    6
         Adverse event, serious fatal
    1
    1
    2
         Consent withdrawn by subject
    1
    -
    -
         Study Terminated by Sponsor
    1
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.

    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.

    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.

    Reporting group values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Total
    Number of subjects
    		 3 6 6
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.7 ( 18.34 ) 63.7 ( 11.64 ) 59.2 ( 12.02 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 2 6
        Male
    		 1 4 4 9
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 4 0 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 2 2
        White
    		 3 0 1 4
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 2 3 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 1 1
        Not Hispanic or Latino
    		 3 4 3 10
        Unknown or Not Reported
    		 0 2 2 4

    End points

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    End points reporting groups
    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.

    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.

    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.

    Subject analysis set title
    Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were planned to receive modakafusp alfa at dose level 1 (DL1) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression. However, the study terminated prior to initiation of Phase 2 and no participants were enrolled in Phase 2 of the study. "15" is added as a placeholder value for "0" in the "number of subjects in subject analysis set" field due to database limitations.

    Subject analysis set title
    Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were planned to receive modakafusp alfa at dose level 2 (DL2) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression. However, the study terminated prior to initiation of Phase 2 and no participants were enrolled in Phase 2 of the study. "15" is added as a placeholder value for "0" in the "number of subjects in subject analysis set" field due to database limitations.

    Primary: Phase 1: Number of Participants Reporting one or More TEAEs and Per Severity

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    End point title
    		 Phase 1: Number of Participants Reporting one or More TEAEs and Per Severity [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs were evaluated as per the NCI CTCAE Version 5.0. The Safety Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug.
    End point type
    Primary
    End point timeframe
    Phase 1: Up to 15.9 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    3
    6
    6
    Units: participants
        Grade 1
    1
    0
    0
        Grade 2
    0
    2
    1
        Grade 3
    2
    4
    3
        Grade 4
    0
    0
    1
        Grade 5
    0
    0
    1
    No statistical analyses for this end point

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

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    End point title
    		 Phase 1: Number of Participants with Dose Limiting Toxicities (DLT) [2]
    End point description
    DLT was defined as any of the treatment-emergent adverse events (TEAEs) that occurred during Cycle 1 and were considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity was evaluated according to national cancer institute common terminology criteria for adverse events (NCI CTCAE) Version 5.0. The Dose Limiting Toxicity (DLT)-evaluable Population included all participants from the Phase 1 dose escalation portion who experienced a DLT in Cycle 1 in the treatment phase of the study or had completed the Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of daratumumab SC.
    End point type
    Primary
    End point timeframe
    Phase 1: Cycle 1 (cycle length=28 days)
    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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    3
    6
    6
    Units: participants
    0
    0
    1
    No statistical analyses for this end point

    Primary: Phase 2a: Overall Response Rate (ORR)

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    End point title
    		 Phase 2a: Overall Response Rate (ORR) [3]
    End point description
    ORR is defined as the percentage of participants who achieve a confirmed partial response (PR) or better during the study in the safety population. ORR will be assessed by the investigator per International Myeloma Working Group (IMWG) criteria. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a and no data was collected for this outcome measure due to study termination.
    End point type
    Primary
    End point timeframe
    Phase 2a: Up to 15.9 months
    Notes
    [3] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: participants
    Notes
    [4] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [5] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa

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    End point title
    		 Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [6] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [7] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [8] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa

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    End point title
    		 Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    Units: hours
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [9] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [10] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [11] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa

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    End point title
    		 Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    Units: nanogram*hour per milliliter (ng*hr/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [12] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [13] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [14] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration

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    End point title
    		 Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [15] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [16] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [17] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa

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    End point title
    		 Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: hour
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [18] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [19] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [20] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa

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    End point title
    		 Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [21]
    0 [22]
    0 [23]
    Units: hour
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [21] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [22] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [23] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa

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    End point title
    		 Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [24]
    0 [25]
    0 [26]
    Units: L/hr
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [24] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [25] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [26] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Volume of Distribution at Steady State After Intravenous (IV) Administration for Modakafusp Alfa

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    End point title
    		 Phase 1: Volume of Distribution at Steady State After Intravenous (IV) Administration for Modakafusp Alfa
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    Units: liters
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [27] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [28] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [29] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab

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    End point title
    		 Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [30] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [31] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [32] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab

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    End point title
    		 Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [33]
    0 [34]
    0 [35]
    Units: hours
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [33] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [34] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [35] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab

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    End point title
    		 Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [36]
    0 [37]
    0 [38]
    Units: micrograms/milliliter (mcg/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [36] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [37] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [38] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for Daratumumab

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    End point title
    		 Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for Daratumumab
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [39]
    0 [40]
    0 [41]
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [39] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [40] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [41] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Daratumumab

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    End point title
    		 Phase 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Daratumumab
    End point description
    Data was not collected for this outcome measure as planned because the study was terminated by the sponsor due to strategic reasons (no safety concerns).
    End point type
    Secondary
    End point timeframe
    Phase 1: Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    0 [42]
    0 [43]
    0 [44]
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Notes
    [42] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [43] - Data was not collected for this outcome measure as planned because the study was terminated early.
    [44] - Data was not collected for this outcome measure as planned because the study was terminated early.
    No statistical analyses for this end point

    Secondary: Phase 1: Overall Response Rate (ORR)

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    End point title
    		 Phase 1: Overall Response Rate (ORR)
    End point description
    ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria. The Response-evaluable Population included all participants who received at least 1 dose, even an incomplete dose, of any study drug, have a disease assessment at screening (baseline evaluation), and at least 1 postbaseline disease assessment.
    End point type
    Secondary
    End point timeframe
    Phase 1: Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    3
    6
    6
    Units: percentage of participants
        number (confidence interval 95%)
    33.3 (0.84 to 90.57)
    66.7 (22.28 to 95.67)
    50.0 (11.81 to 88.19)
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Duration of Response (DOR)

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    End point title
    		 Phase 1 and Phase 2a: Duration of Response (DOR)
    End point description
    DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DOR will be calculated for confirmed responders only (PR or better). DOR will be assessed by the investigator as per IMWG criteria. Due to the early study termination, the short follow-up of the participants, and the small population, the pre-planned efficacy analysis could not be adequately interpreted for Phase 1. Furthermore, for strategic reasons, the sponsor decided not to proceed with Phase 2a. Thus, no participants were enrolled in Phase 2a, and no data was collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [45]
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    Units: months
    Notes
    [45] - The pre-planned efficacy analysis could not be adequately interpreted for Phase 1.
    [46] - The pre-planned efficacy analysis could not be adequately interpreted for Phase 1.
    [47] - The pre-planned efficacy analysis could not be adequately interpreted for Phase 1.
    [48] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [49] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Progression Free Survival (PFS)

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    End point title
    		 Phase 1 and Phase 2a: Progression Free Survival (PFS)
    End point description
    PFS is defined as the time from the date of the first dose administration of any study drug to the first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. PFS will be assessed by the investigator as per IMWG criteria. Due to the early study termination, the short follow-up of the participants, and the small population, the pre-planned efficacy analysis could not be adequately interpreted for Phase 1. Furthermore, for strategic reasons, the sponsor decided not to proceed with Phase 2a. Thus, no participants were enrolled in Phase 2a, and no data was collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [50]
    0 [51]
    0 [52]
    0 [53]
    0 [54]
    Units: months
    Notes
    [50] - The pre-planned efficacy analysis could not be adequately interpreted for Phase 1.
    [51] - The pre-planned efficacy analysis could not be adequately interpreted for Phase 1.
    [52] - The pre-planned efficacy analysis could not be adequately interpreted for Phase 1.
    [53] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [54] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Overall Survival (OS)

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    End point title
    		 Phase 1 and Phase 2a: Overall Survival (OS)
    End point description
    OS is defined as the time from the date of the first dose administration of any study drug to the documentation of death due to any cause. OS will be assessed by the investigator as per IMWG criteria. Due to the early study termination, the short follow-up of the participants, and the small population, the pre-planned efficacy analysis could not be adequately interpreted for Phase 1. Furthermore, for strategic reasons, the sponsor decided not to proceed with Phase 2a. Thus, no participants were enrolled in Phase 2a, and no data was collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [55]
    0 [56]
    0 [57]
    0 [58]
    0 [59]
    Units: months
    Notes
    [55] - The preplanned efficacy analysis could not be adequately interpreted for Phase 1.
    [56] - The preplanned efficacy analysis could not be adequately interpreted for Phase 1.
    [57] - The preplanned efficacy analysis could not be adequately interpreted for Phase 1.
    [58] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [59] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies (ADA)

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    End point title
    		 Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies (ADA)
    End point description
    After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons and hence no participants were enrolled for Phase 2a. Immunogenicity-evaluable Population included participants who received at least 1 dose of modakafusp alfa in combination with daratumumab SC (partial or complete) with a baseline assessment & at least 1 postbaseline immunogenicity assessment. No data was collected for this outcome measure due to study termination. Subjects analyzed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Number of subjects analysed
    3
    6
    0 [60]
    Units: participants
    3
    2
    Notes
    [60] - No participant in this arm group had data available for analyses at the specified time point.
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Titer of Anti-drug Antibodies

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    End point title
    		 Phase 1 and Phase 2a: Titer of Anti-drug Antibodies
    End point description
    Due to early termination and small evaluable population, the pre-planned immunogenicity measurements of serum titers were not performed for Phase 1. Furthermore, for strategic reasons, the sponsor decided not to proceed with Phase 2a. Thus, no participants were enrolled in Phase 2a, and no data was collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    0 [65]
    Units: percentage of participants
    Notes
    [61] - The preplanned immunogenicity measurements of serum titers were not performed for Phase 1.
    [62] - The preplanned immunogenicity measurements of serum titers were not performed for Phase 1.
    [63] - The preplanned immunogenicity measurements of serum titers were not performed for Phase 1.
    [64] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [65] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Number of Participants With Neutralizing Antibodies (NAb) Against Study Drug

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    End point title
    		 Phase 1 and Phase 2a: Number of Participants With Neutralizing Antibodies (NAb) Against Study Drug
    End point description
    Immunogenicity-evaluable Population. After Phase 1 Dose Escalation, the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination. Subjects analyzed=participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    3
    6
    0 [66]
    0 [67]
    0 [68]
    Units: participants
    1
    0
    Notes
    [66] - No participant had the data available for analysis at the specified time point.
    [67] - No participants were enrolled in Phase 2a due to early study termination.
    [68] - No participants were enrolled in Phase 2a due to early study termination.
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Rate of Measurable [Minimal] Residual Disease Negative (MRD[-]) Complete Response (CR)

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    End point title
    		 Phase 1 and Phase 2a: Rate of Measurable [Minimal] Residual Disease Negative (MRD[-]) Complete Response (CR)
    End point description
    MRD[-] CR rate is defined as the percentage of participants who achieve confirmed CR assessed by the investigator and MRD[-] status using a threshold of 10^-5. The analysis will be based on the response-evaluable population. No participants had sCR or CR in Phase 1 thus the subjects analyzed is zero. Only participants who had a confirmed stringent CR (sCR) or complete response (CR) were to be analyzed for this outcome measure. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [69]
    0 [70]
    0 [71]
    0 [72]
    0 [73]
    Units: percentage of participants
    Notes
    [69] - No participant had sCR or CR in Phase 1 thus the subjects analysed is zero.
    [70] - No participant had sCR or CR in Phase 1 thus the subjects analysed is zero.
    [71] - No participant had sCR or CR in Phase 1 thus the subjects analysed is zero.
    [72] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [73] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity

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    End point title
    		 Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity
    End point description
    Duration of MRD negativity for participants achieving MRD negativity is defined as the time from the date of first documentation of MRD negativity to the first documentation of MRD positivity or confirmed progressive disease, whichever occurs first. It will be calculated for participants achieving MRD negativity only. No participants had sCR or CR in Phase 1 thus the subjects analyzed is zero.
    End point type
    Secondary
    End point timeframe
    Up to 15.9 months
    End point values
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [74]
    0 [75]
    0 [76]
    0 [77]
    0 [78]
    Units: months
    Notes
    [74] - No participant had sCR or CR in Phase 1 thus the subjects analyzed is zero.
    [75] - No participant had sCR or CR in Phase 1 thus the subjects analyzed is zero.
    [76] - No participants had sCR or CR in Phase 1 thus the subjects analyzed is zero.
    [77] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [78] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Duration of Clinical Benefit (DCB)

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    End point title
    		 Phase 2a: Duration of Clinical Benefit (DCB)
    End point description
    DCB is defined as the time from the date of first documentation of a minimal response or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DCB will be calculated for only participants who achieved a minimal response or better. DCB will be assessed by the investigator as per IMWG criteria. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [79]
    0 [80]
    Units: months
    Notes
    [79] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [80] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Clinical Benefit Rate (CBR)

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    End point title
    		 Phase 2a: Clinical Benefit Rate (CBR)
    End point description
    CBR is defined as the percentage of participants who had a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response based on investigators' disease assessment per IMWG criteria. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [81]
    0 [82]
    Units: percentage of participants
    Notes
    [81] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [82] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Disease Control Rate (DCR)

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    End point title
    		 Phase 2a: Disease Control Rate (DCR)
    End point description
    DCR is defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, minimal response, or stable disease (SD) based on investigators' disease assessment per IMWG criteria. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [83]
    0 [84]
    Units: percentage of participants
    Notes
    [83] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [84] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Duration of Disease Control

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    End point title
    		 Phase 2a: Duration of Disease Control
    End point description
    Duration of disease control is defined as the time from date of first documentation of SD or better to the date of first documentation of confirmed progressive disease or death due to any cause. Duration of disease control will be calculated for only patients who achieved SD or better. It will be assessed by the investigator per IMWG criteria. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [85]
    0 [86]
    Units: months
    Notes
    [85] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [86] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Time to Progression (TTP)

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    End point title
    		 Phase 2a: Time to Progression (TTP)
    End point description
    TTP is defined as the time from the date of randomization to the first documentation of confirmed progressive disease as defined by IMWG criteria, assessed by the investigator. Participants without documentation of confirmed progression will be censored at the date of last adequate disease assessment. The analysis will be based on the intent-to-treat (ITT) population. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [87]
    0 [88]
    Units: months
    Notes
    [87] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [88] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Time to Next Treatment (TTNT)

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    End point title
    		 Phase 2a: Time to Next Treatment (TTNT)
    End point description
    TTNT is defined as the time from the date of first dose administration of any study drug to the date of the first dose initiation of the next line of anticancer therapy for any reason or death from any cause, whichever comes first. Participants who have not started the next-line therapy will be censored at the date last known to be alive before subsequent anticancer therapy. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [89]
    0 [90]
    Units: days
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [89] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [90] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Time to Response (TTR)

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    End point title
    		 Phase 2a: Time to Response (TTR)
    End point description
    TTR is defined as time from the date of first dose administration of any study drug to the date of the first documentation of a confirmed PR or better. TTR will be calculated for responders only. TTR will be assessed by the investigator per IMWG criteria. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [91]
    0 [92]
    Units: months
    Notes
    [91] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [92] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Secondary: Phase 2a: Number of Participants Reporting one or More TEAEs and Per Severity

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    End point title
    		 Phase 2a: Number of Participants Reporting one or More TEAEs and Per Severity
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs will be evaluated as per the NCI CTCAE Version 5.0. After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a & no data was collected for this outcome measure due to study termination.
    End point type
    Secondary
    End point timeframe
    Phase 2a: Up to 15.9 months
    End point values
    		 Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
    Number of subjects analysed
    0 [93]
    0 [94]
    Units: participants
    Notes
    [93] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    [94] - Due to early study termination no participants were enrolled in Phase 2a of the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Phase 1: Up to 15.9 months
    Adverse event reporting additional description
    The Safety Population was defined as all participants who received at least 1 dose, even an incomplete dose, of any study drug. The sponsor decided not to proceed with Phase 2a after phase 1 completion due to strategic reasons. Thus, no participants were enrolled & no adverse events were reported for Phase 2a.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 80 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 60 weeks.

    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 240 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 36 weeks.

    Reporting group title
    Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
    Reporting group description
    		 Participants received modakafusp alfa 120 mg, infusion, IV, Q4W with daratumumab 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression or up to 48 weeks.

    Serious adverse events
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    1
    2
    1
         number of deaths resulting from adverse events
    0
    1
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Phase 1 (Dose Escalation) Modakafusp Alfa 80 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 240 mg + Daratumumab Phase 1 (Dose Escalation) Modakafusp Alfa 120 mg + Daratumumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    2
    Chills
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    2
    Pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site erythema
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    3 / 3 (100.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    7
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    Dyspnoea
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    Anxiety
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    7
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Fall
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    0
    1
    Nervous system disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 6 (66.67%)
    1 / 6 (16.67%)
         occurrences all number
    0
    4
    2
    Leukopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 3 (66.67%)
    4 / 6 (66.67%)
    3 / 6 (50.00%)
         occurrences all number
    2
    8
    11
    Neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 6 (66.67%)
    3 / 6 (50.00%)
         occurrences all number
    1
    10
    5
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Dry eye
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    Dry mouth
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hypogonadism
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 3 (100.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    1
    Muscular weakness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    Rash pustular
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hypercreatininaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    0
    Decreased appetite
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperphagia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Apr 2024
    The following changes were made as per Amendment 01: 1. Removed the criteria related to Grade 4 life threatening TEAEs. 2. Modified phase name to indicate “dose escalation” rather than “safety lead-in”.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 May 2024
    No participants were enrolled in Phase 2a (Dose Finding) and data for the outcome measures related to progression-free survival (PFS), overall survival (OS), duration of response (DOR), pharmacokinetic (PK) parameters and pharmacodynamic (PD)/antidrug antibodies (ADAs) was not collected or analysed as planned because the study was terminated by the sponsor due to strategic reasons.
    -

    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
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