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    Clinical Trial Results:
    A Phase 2, Multi-Arm Study of Magrolimab in Patients with Solid Tumors

    Summary
    EudraCT number
    		 2020-005265-14
    Trial protocol
    		 ES   FR  
    Global end of trial date
    01 Oct 2024

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-548-5918
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04827576
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    01 Oct 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The goals of this clinical study was to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with docetaxel in participants with solid tumors.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2021
    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
    France: 18
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    106
    EEA total number of subjects
    64
    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)
    57
    From 65 to 84 years
    49
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Spain, Poland, France, United States and the United Kingdom.

    Pre-assignment
    Screening details
    		 159 participants were screened.

    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
    Yes

    Arm title
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel)
    Arm description
    		 Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) received 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously

    Investigational medicinal product name
    Magrolimab
    Investigational medicinal product code
    Other name
    GS-4721
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously

    Arm title
    		 Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
    Arm description
    		 Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously.

    Investigational medicinal product name
    Magrolimab
    Investigational medicinal product code
    Other name
    GS-4721
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously.

    Arm title
    		 Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
    Arm description
    		 Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously.

    Investigational medicinal product name
    Magrolimab
    Investigational medicinal product code
    Other name
    GS-4721
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously.

    Arm title
    		 Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Arm description
    		 Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously

    Investigational medicinal product name
    Magrolimab
    Investigational medicinal product code
    Other name
    GS-4721
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously

    Number of subjects in period 1
    		Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Started
    9
    29
    26
    42
    Completed
    0
    0
    0
    0
    Not completed
    9
    29
    26
    42
         Consent withdrawn by subject
    -
    3
    -
    -
         Lost to follow-up
    1
    -
    -
    -
         Death
    5
    17
    17
    32
         Investigator's Discretion
    1
    -
    2
    5
         Study Terminated by Sponsor
    2
    9
    7
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Safety Run-in Cohort 1 (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) received 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days.

    Reporting group values
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) Total
    Number of subjects
    		 9 29 26 42 106
    Age categorical
    Units: Subjects
        Between 18 and 65 years
    		 5 13 12 27 57
        >=65 years
    		 4 16 14 15 49
    Gender categorical
    Units: Subjects
        Female
    		 4 6 7 17 34
        Male
    		 5 23 19 25 72
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 1 1 1 0 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 1 0 0 1 2
        White
    		 7 27 19 30 83
        More than one race
    		 0 0 0 11 18
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 3 0 1 4
        Not Hispanic or Latino
    		 8 25 20 30 83
        Unknown or Not Reported
    		 1 1 6 11 19

    End points

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    End points reporting groups
    Reporting group title
    Safety Run-in Cohort 1 (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) received 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days.

    Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    TEAEs were defined as any adverse events (AE) not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. The TEAE reporting period is defined as the period from the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment or the day before initiation of subsequent antineoplastic therapy, whichever comes first. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Analysis Population Description: Participants in the Safety Analysis Set were analyzed. The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
    End point type
    Primary
    End point timeframe
    First dose date up to 113 weeks plus 30 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    9
    29
    26
    42
    Units: percentage of participants
        number (not applicable)
    100.0
    100.0
    100.0
    100.0
    No statistical analyses for this end point

    Primary: Percentage of Participants With Treatment-Emergent Laboratory Abnormalities

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    End point title
    		 Percentage of Participants With Treatment-Emergent Laboratory Abnormalities [2]
    End point description
    Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day of initiation of subsequent anti-cancer therapy. Percentages were rounded off. Analysis Population Description: Participants in the Safety Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    First dose date up to 113 weeks plus 30 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: No statistical comparison was planned or performed.
    End point values
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    9
    29
    26
    42
    Units: percentage of participants
    number (not applicable)
        Any Grade
    100
    100
    100
    100
        Grade 3 or Higher
    77.8
    82.8
    92.3
    78.6
    No statistical analyses for this end point

    Primary: Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)

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    End point title
    		 Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) [3] [4]
    End point description
    ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson method was used in outcome measure analysis. Percentages were rounded-off. Analysis Population Description: Participants in the modified intent to treat analysis set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported.
    End point type
    Primary
    End point timeframe
    Up to 90 Weeks
    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: The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis ,this endpoint was applicable only to Phase 2 arms. Therefore, data for arms of Phase 2 are reported.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis ,this endpoint was applicable only to Phase 2 arms. Therefore, data for arms of Phase 2 are reported.
    End point values
    		 Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    29
    26
    42
    Units: percentage of participants
        number (confidence interval 95%)
    17.2 (5.8 to 35.8)
    3.8 (0.1 to 19.6)
    4.8 (0.6 to 16.2)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c)

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    End point title
    		 Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) [5]
    End point description
    PFS was defined as the interval from the first dosing date of any study drug to the earlier date of the first documentation of objective disease progression (PD) by investigator assessment per RECIST, Version 1.1, or death from any cause. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (appearance of one or more new lesions was also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis. Analysis Population Description: Participants in the modified Intent-to-Treat Analysis Set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported.
    End point type
    Secondary
    End point timeframe
    Up to 117 Weeks
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis ,this endpoint was applicable only to Phase 2 arms. Therefore, data for arms of Phase 2 are reported.
    End point values
    		 Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    29
    26
    42
    Units: months
        median (confidence interval 95%)
    4.2 (2.0 to 8.0)
    2.7 (2.1 to 4.0)
    2.2 (2.0 to 3.9)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c)

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    End point title
    		 Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) [6]
    End point description
    DOR was defined as time from first documentation of CR or PR to the earliest date of documented PD, per RECIST, Version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment. CR and PR are defined in endpoint #3 and PD is defined in endpoint#4. KM Estimates were used in endpoint analysis. Analysis Population Description: Participants in the modified Intent-to-Treat Analysis Set who achieved CR or PR were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported. 0000/9999 means data is not available
    End point type
    Secondary
    End point timeframe
    Up to 117 Weeks
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis ,this endpoint was applicable only to Phase 2 arms. Therefore, data for arms of Phase 2 are reported.
    End point values
    		 Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    5
    1
    2
    Units: months
        median (confidence interval 95%)
    7.6 (3.7 to 9999)
    9999 (9999 to 9999)
    4.7 (4.6 to 9999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c)

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    End point title
    		 Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) [7]
    End point description
    OS is defined as time from date of dose initiation to death from any cause. KM estimates were used in endpoint analysis. Analysis Population Description: Participants in the modified Intent-to-Treat Analysis Set were analyzed. The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis, this endpoint was applicable only to Phase 2 cohorts. Therefore, data for cohorts of Phase 2 are reported. 9999: Upper limit of confidence interval was not estimable due to low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Up to 117 Weeks
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The study had 2 parts - Safety Run-in and Phase 2. Per pre-specified analysis ,this endpoint was applicable only to Phase 2 arms. Therefore, data for arms of Phase 2 are reported.
    End point values
    		 Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    29
    26
    42
    Units: months
        median (confidence interval 95%)
    9.8 (5.2 to 9999)
    7.6 (4.7 to 13.7)
    6.4 (3.9 to 8.3)
    No statistical analyses for this end point

    Secondary: Serum Concentration of Magrolimab

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    End point title
    		 Serum Concentration of Magrolimab
    End point description
    Analysis Population Description: The participants in the Pharmacokinetic (PK) Analysis Set with available data were analyzed. The PK Analysis Set included all participants who received any amount of magrolimab and have at least 1 measurable posttreatment serum concentration of magrolimab. 9999 : Standard Deviation (SD) is not estimable for 1 participant. Here 'N' is defined as participants with available data at the given timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8 Predose, Day 8 1-Hour Postdose, Day 22, Day 43 Predose, Day 43 1-Hour Postdose, Day 85, Day 127, Day 190 and Day 253 Predose
    End point values
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    7
    23
    23
    36
    Units: μg/mL
    arithmetic mean (standard deviation)
        D 1 Predose
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        D 8 Predose N=5,20,22,29
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        D 8 1-Hour Postdose N=1
    407 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
        D 22 Predose N=4,23,23,32
    460 ( 112 )
    302 ( 161 )
    260 ( 148 )
    334 ( 134 )
        D 43 Predose N=5,20,21,28
    624 ( 451 )
    523 ( 195 )
    439 ( 182 )
    529 ( 258 )
        D 43 1- Hour Postdose N=2,18,18,27
    1880 ( 523 )
    1550 ( 525 )
    1560 ( 492 )
    1730 ( 560 )
        D 85 Predose N=4,14,12,15
    415 ( 135 )
    266 ( 134 )
    319 ( 271 )
    297 ( 181 )
        D 127 Predose N=3,11,3,10
    277 ( 35.0 )
    281 ( 143 )
    393 ( 93.8 )
    174 ( 106 )
        D 190 Predose N=3,7,4
    281 ( 71.1 )
    344 ( 104 )
    9999 ( 9999 )
    250 ( 113 )
        D 253 Predose N=2,6
    237 ( 56.6 )
    363 ( 179 )
    9999 ( 9999 )
    9999 ( 9999 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Developed Anti-Magrolimab Antibodies

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    End point title
    		 Percentage of Participants who Developed Anti-Magrolimab Antibodies
    End point description
    Analysis Population Description:: Participants in the Immunogenicity Analysis Set with available data were analyzed. The Immunogenicity Analysis Set includes all participants who received any amount of magrolimab and have at least 1 evaluable anti-magrolimab antibody test result.
    End point type
    Secondary
    End point timeframe
    Up to 113 Weeks
    End point values
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Number of subjects analysed
    7
    25
    25
    37
    Units: percentage of participants
        number (not applicable)
    0
    4.0
    8.0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality: Up to 117 weeks; Adverse events: Up to 113 weeks plus 30 days
    Adverse event reporting additional description
    All-cause mortality: All Enrolled Analysis Set included all participants who received a study subject identification number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Safety Run-in Cohort 1 (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with solid tumors (including metastatic non small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), and metastatic small cell lung cancer (mSCLC)) received 1 mg/kg magrolimab intravenously (IV) on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 113 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 113 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 72 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 72 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mUC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 68 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 68 weeks; each cycle length = 21 days.

    Reporting group title
    Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
    Reporting group description
    		 Participants with mNSCLC received 1 mg/kg magrolimab IV on Day 1, 30 mg/kg IV on Days 8 and 15 of cycle 1; 30 mg/kg IV on Days 1, 8 and 15 of Cycle 2; 60 mg/kg IV on Day 1 of Cycle 3 and onwards for up to 90 weeks; and 75 mg/m^2 docetaxel IV on Day 1 of each cycle for up to 69 weeks; each cycle length = 21 days.

    Serious adverse events
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 9 (55.56%)
    18 / 42 (42.86%)
    12 / 26 (46.15%)
    16 / 29 (55.17%)
         number of deaths (all causes)
    6
    37
    18
    17
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary ~ disease
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 42 (4.76%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Investigations
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Transfusion reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 42 (4.76%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuritis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    4 / 26 (15.38%)
    3 / 29 (10.34%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
    4 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    2 / 26 (7.69%)
    3 / 29 (10.34%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
    3 / 5
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Inappropriate antidiuretic hormone ~ secretion
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    1 / 26 (3.85%)
    4 / 29 (13.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    2 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Encephalitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Run-in Cohort 1 (Magrolimab + Docetaxel) Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    41 / 42 (97.62%)
    26 / 26 (100.00%)
    29 / 29 (100.00%)
    Vascular disorders
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    0 / 26 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    2
    2
    0
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 9 (66.67%)
    11 / 42 (26.19%)
    5 / 26 (19.23%)
    6 / 29 (20.69%)
         occurrences all number
    6
    14
    5
    6
    Oedema peripheral
         subjects affected / exposed
    3 / 9 (33.33%)
    4 / 42 (9.52%)
    5 / 26 (19.23%)
    6 / 29 (20.69%)
         occurrences all number
    3
    4
    5
    7
    Chills
         subjects affected / exposed
    1 / 9 (11.11%)
    4 / 42 (9.52%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    5
    2
    0
    Mucosal inflammation
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Influenza like illness
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    3 / 26 (11.54%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Pyrexia
         subjects affected / exposed
    3 / 9 (33.33%)
    8 / 42 (19.05%)
    8 / 26 (30.77%)
    11 / 29 (37.93%)
         occurrences all number
    3
    10
    9
    19
    Asthenia
         subjects affected / exposed
    1 / 9 (11.11%)
    23 / 42 (54.76%)
    10 / 26 (38.46%)
    18 / 29 (62.07%)
         occurrences all number
    1
    25
    18
    25
    Generalised oedema
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular device occlusion
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Malaise
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immune system disorders
    Contrast media reaction
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Hiccups
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Dysphonia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    2
    1
    Cough
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 42 (11.90%)
    2 / 26 (7.69%)
    4 / 29 (13.79%)
         occurrences all number
    4
    5
    2
    7
    Dyspnoea
         subjects affected / exposed
    2 / 9 (22.22%)
    12 / 42 (28.57%)
    3 / 26 (11.54%)
    9 / 29 (31.03%)
         occurrences all number
    2
    13
    3
    12
    Sneezing
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    2
    2
    Depression
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    3
    1
    0
    2
    Anxiety
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Confusional state
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    2
    0
    0
    2
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    5
    0
    0
    7
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 42 (7.14%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Weight decreased
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 42 (7.14%)
    2 / 26 (7.69%)
    1 / 29 (3.45%)
         occurrences all number
    2
    3
    2
    1
    Neutrophil count decreased
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 42 (7.14%)
    0 / 26 (0.00%)
    4 / 29 (13.79%)
         occurrences all number
    5
    7
    0
    7
    C-reactive protein increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Sars-cov-2 test positive
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 9 (11.11%)
    5 / 42 (11.90%)
    2 / 26 (7.69%)
    4 / 29 (13.79%)
         occurrences all number
    1
    8
    2
    4
    Transfusion reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 9 (11.11%)
    6 / 42 (14.29%)
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    6
    1
    1
    Dysgeusia
         subjects affected / exposed
    1 / 9 (11.11%)
    6 / 42 (14.29%)
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    1
    6
    2
    2
    Headache
         subjects affected / exposed
    2 / 9 (22.22%)
    6 / 42 (14.29%)
    2 / 26 (7.69%)
    1 / 29 (3.45%)
         occurrences all number
    2
    7
    2
    1
    Neurotoxicity
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 42 (9.52%)
    1 / 26 (3.85%)
    6 / 29 (20.69%)
         occurrences all number
    0
    4
    1
    8
    Migraine
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    0
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    3
    4
    Thrombocytopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    5 / 26 (19.23%)
    3 / 29 (10.34%)
         occurrences all number
    0
    4
    8
    3
    Leukopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 42 (9.52%)
    4 / 26 (15.38%)
    5 / 29 (17.24%)
         occurrences all number
    0
    5
    4
    5
    Neutropenia
         subjects affected / exposed
    0 / 9 (0.00%)
    16 / 42 (38.10%)
    13 / 26 (50.00%)
    13 / 29 (44.83%)
         occurrences all number
    0
    19
    17
    17
    Febrile neutropenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Leukocytosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Anaemia
         subjects affected / exposed
    5 / 9 (55.56%)
    26 / 42 (61.90%)
    14 / 26 (53.85%)
    22 / 29 (75.86%)
         occurrences all number
    7
    37
    21
    38
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 9 (33.33%)
    16 / 42 (38.10%)
    4 / 26 (15.38%)
    5 / 29 (17.24%)
         occurrences all number
    4
    20
    4
    6
    Diarrhoea
         subjects affected / exposed
    2 / 9 (22.22%)
    19 / 42 (45.24%)
    6 / 26 (23.08%)
    14 / 29 (48.28%)
         occurrences all number
    5
    22
    6
    21
    Dysphagia
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    1
    0
    1
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    6 / 42 (14.29%)
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    0
    8
    1
    2
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    5 / 42 (11.90%)
    3 / 26 (11.54%)
    4 / 29 (13.79%)
         occurrences all number
    0
    5
    4
    6
    Vomiting
         subjects affected / exposed
    2 / 9 (22.22%)
    7 / 42 (16.67%)
    4 / 26 (15.38%)
    4 / 29 (13.79%)
         occurrences all number
    5
    9
    4
    6
    Constipation
         subjects affected / exposed
    2 / 9 (22.22%)
    8 / 42 (19.05%)
    4 / 26 (15.38%)
    6 / 29 (20.69%)
         occurrences all number
    3
    8
    4
    6
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    1 / 26 (3.85%)
    4 / 29 (13.79%)
         occurrences all number
    1
    2
    1
    4
    Alopecia
         subjects affected / exposed
    2 / 9 (22.22%)
    6 / 42 (14.29%)
    6 / 26 (23.08%)
    8 / 29 (27.59%)
         occurrences all number
    2
    6
    6
    8
    Nail discolouration
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nail disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    1
    2
    Rash
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 42 (0.00%)
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    3
    0
    2
    2
    Renal and urinary disorders
    Cystitis noninfective
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    2 / 26 (7.69%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Pollakiuria
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
    5 / 42 (11.90%)
    4 / 26 (15.38%)
    6 / 29 (20.69%)
         occurrences all number
    1
    7
    4
    8
    Back pain
         subjects affected / exposed
    2 / 9 (22.22%)
    6 / 42 (14.29%)
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    2
    8
    2
    2
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    5 / 42 (11.90%)
    3 / 26 (11.54%)
    1 / 29 (3.45%)
         occurrences all number
    0
    5
    3
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 42 (4.76%)
    1 / 26 (3.85%)
    5 / 29 (17.24%)
         occurrences all number
    0
    2
    1
    5
    Pain in extremity
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 42 (9.52%)
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    0
    4
    1
    2
    Bone pain
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Flank pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    3 / 26 (11.54%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Muscular weakness
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    0
    0
    1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 42 (9.52%)
    1 / 26 (3.85%)
    3 / 29 (10.34%)
         occurrences all number
    0
    4
    1
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 42 (4.76%)
    4 / 26 (15.38%)
    0 / 29 (0.00%)
         occurrences all number
    1
    2
    7
    0
    Candida infection
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 42 (7.14%)
    1 / 26 (3.85%)
    1 / 29 (3.45%)
         occurrences all number
    0
    3
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    2
    1
    0
    3
    Covid-19
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 42 (2.38%)
    1 / 26 (3.85%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    4
    Fungal infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Localised infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nail infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Osteomyelitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 42 (7.14%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    3
    3
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 9 (22.22%)
    17 / 42 (40.48%)
    2 / 26 (7.69%)
    7 / 29 (24.14%)
         occurrences all number
    2
    20
    2
    8
    Hyponatraemia
         subjects affected / exposed
    2 / 9 (22.22%)
    4 / 42 (9.52%)
    1 / 26 (3.85%)
    5 / 29 (17.24%)
         occurrences all number
    2
    5
    1
    6
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    4 / 42 (9.52%)
    2 / 26 (7.69%)
    2 / 29 (6.90%)
         occurrences all number
    3
    5
    2
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    1 / 26 (3.85%)
    0 / 29 (0.00%)
         occurrences all number
    3
    1
    1
    0
    Dehydration
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 42 (2.38%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 42 (4.76%)
    3 / 26 (11.54%)
    1 / 29 (3.45%)
         occurrences all number
    4
    2
    3
    2
    Hypokalaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    4 / 42 (9.52%)
    0 / 26 (0.00%)
    5 / 29 (17.24%)
         occurrences all number
    0
    4
    0
    5
    Hypoglycaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Iron overload
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 42 (0.00%)
    0 / 26 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    3
    0
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2021
    Herein is a summary of the major changes made to original protocol dated 15 December 2020 and reflected in Amendment 1 dated 03 March 2021. The protocol has been amended primarily to: - Modify various sections of the protocol to reflect the removal of the triple negative breast (TNBC) cancer cohorts, in response to initial regulatory feedback received from the FDA during the initial review of this protocol. This amendment removed the Safety Run-in Cohort 1 (Magrolimab + Nab-paclitaxel) and the Phase 2 Cohort 1a (mTNBC). The TNBC Cohorts will be a separate study under a different IND. - Other sections of the protocol also revised to address regulatory feedback from the Food and Drug Administration (FDA) include clarifying eligibility criteria for small cell lung cancer (SCLC) and the definition of dose-limiting toxicity (DLT). - In response to regulatory feedback received from International Health Authorities, language throughout the protocol has been harmonized with ongoing studies of magrolimab. - Clarification of key study procedures. - Biomarker sample collection timepoints at screening, Cycle 1, and the end of treatment have been adjusted to reflect current data needs for the characterization of the mechanism of action of magrolimab in solid tumors and for harmonization with other magrolimab solid tumor studies.
    15 Mar 2021
    Herein is a summary of the major changes made to Amendment 1 dated 03 March 2021 and reflected in Amendment 2 dated 15 March 2021. The protocol has been amended to address feedback received from the FDA. The sections revised are as follows: - Modify the exceptions to dose-limiting toxicity (DLT) definition for electrolyte abnormalities, tumor lysis, and hypomagnesemia.
    14 Dec 2021
    This amendment provides the modification of the magrolimab dosing in Cycles 3 and beyond to 60 mg/kg (every 3 weeks) and guidance on dose delays of magrolimab in case of TEAEs.
    27 Jan 2022
    The primary reason for this amendment is to provide additional guidance for enhanced anemia management. Anemia is a known and well-described risk for magrolimab that can occur in early doses and is transient. Adequate monitoring and management of anemia during the first 2 doses of magrolimab are needed to ensure patient safety, especially in patients with low baseline hemoglobin. A minimum hemoglobin threshold prior to the first 2 doses of magrolimab treatment during treatment initiation along with post magrolimab treatment hemoglobin monitoring during those treatments are included in the amended protocol.
    24 Oct 2023
    High-level summaries of the history of this study’s amendments are provided in tabular form in the subsections below (from most recent amendment to oldest), with changes listed in each table in order of importance. Minor changes such as the correction of typographic errors, grammar, or formatting are not detailed. - Collection period for treatment-emergent adverse events clarified. - Collection period for incidence of treatment-emergent laboratory abnormalities - clarified. - Updates made to align with current safety recommendations. - Timing of primary analysis for Phase 2 Cohort 1 clarified. - Updated the toxicity management regarding hemoglobin monitoring to align with current recommendations. - Remove circulating tumor cell sample collection as not performed. - Sample size for urothelial cancer cohort updated. - Magrolimab administration language updated to clarify vital signs will be - assessed prior to administration. Sections 5.4 - Language added to allow local sourcing of docetaxel. Section 5.3.2 - Updated guidance provided for the management of infusion-related reactions. - New sections provided for guidance on management of severe neutropenia and serious infections. - Text added to align with EU-CTR requirements. - Text updated to clarify that ‘urine or serum pregnancy tests will be conducted from Cycle 1 Day 1’ with respect to pregnancy test. - Analysis sets updated. - Guidance on COVID-19 vaccination provided. Section 5.7.1.1 - Language updated to clarify that a final analysis may be conducted after the primary analysis. - Inclusion criteria were updated for clarification. Synopsis; Section 4.2 - Text was updated to replace ‘participants’ with ‘patients’ to maintain consistency. - Changes from administrative amendment 1 were added to the protocol. - Changes from administrative amendment 2 were added to the protocol. - Minor changes to correct typographic errors.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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