Trial Outcomes & Findings for Study of Magrolimab in Patients With Solid Tumors (NCT NCT04827576)

Last Updated: 2025-05-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

106 participants

Primary outcome timeframe

First dose date up to 113 weeks plus 30 days

Results posted on

2025-05-08

Participant Flow

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

159 participants were screened.

Participant milestones

Participant milestones
Measure	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) 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.	Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) 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.	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) 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.
Overall Study STARTED	9	29	26	42
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	9	29	26	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) 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.	Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) 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.	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) 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.
Overall Study Death	5	17	17	32
Overall Study Study Terminated by Sponsor	2	9	7	5
Overall Study Investigator's Discretion	1	0	2	5
Overall Study Withdrew Consent	0	3	0	0
Overall Study Lost to Follow-up	1	0	0	0

Baseline Characteristics

Study of Magrolimab in Patients With Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=9 Participants 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.	Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel) n=29 Participants 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.	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=26 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=42 Participants 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.	Total~(N=106) n=106 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	27 Participants n=4 Participants	57 Participants n=21 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	15 Participants n=4 Participants	49 Participants n=21 Participants
Age, Continuous	66 years STANDARD_DEVIATION 8.2 • n=5 Participants	63 years STANDARD_DEVIATION 10.8 • n=7 Participants	65 years STANDARD_DEVIATION 9.8 • n=5 Participants	62 years STANDARD_DEVIATION 6.6 • n=4 Participants	63 years STANDARD_DEVIATION 8.9 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants	34 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	23 Participants n=7 Participants	19 Participants n=5 Participants	25 Participants n=4 Participants	72 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	25 Participants n=7 Participants	20 Participants n=5 Participants	30 Participants n=4 Participants	83 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	27 Participants n=7 Participants	19 Participants n=5 Participants	30 Participants n=4 Participants	83 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	17 Participants n=7 Participants	9 Participants n=5 Participants	14 Participants n=4 Participants	40 Participants n=21 Participants
Region of Enrollment United States	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	12 Participants n=4 Participants	39 Participants n=21 Participants
Region of Enrollment France	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment Poland	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: First dose date up to 113 weeks plus 30 days

Population: 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.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=29 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=26 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=9 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=42 Participants 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.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

PRIMARY outcome

Timeframe: First dose date up to 113 weeks plus 30 days

Population: Participants in the Safety Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=29 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=26 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=9 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=42 Participants 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.
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Any Grade	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Participants With Treatment-Emergent Laboratory Abnormalities Grade 3 or Higher	82.8 percentage of participants	92.3 percentage of participants	77.8 percentage of participants	78.6 percentage of participants

PRIMARY outcome

Timeframe: Up to 90 Weeks

Population: 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.

ORR was defined as the percentage of participants who achieved 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.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=26 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=42 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=29 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) 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.
Objective Response Rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)	3.8 percentage of participants Interval 0.1 to 19.6	4.8 percentage of participants Interval 0.6 to 16.2	17.2 percentage of participants Interval 5.8 to 35.8	—

SECONDARY outcome

Timeframe: Up to 117 Weeks

Population: 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.

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. (the appearance of one or more new lesions was also considered progression). Kaplan-Meier (KM) estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=26 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=42 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=29 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) 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.
Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c)	2.7 months Interval 2.1 to 4.0	2.2 months Interval 2.0 to 3.9	4.2 months Interval 2.0 to 8.0	—

SECONDARY outcome

Timeframe: Up to 117 Weeks

Population: 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.

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 outcome measure #3 and PD is defined in outcome measure #4. KM Estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=1 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=2 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=5 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) 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.
Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c)	NA months Median, lower and upper limit of confidence interval were not estimable due to low number of participants with events.	4.7 months Interval 4.6 to Upper limit of confidence interval was not estimable due to low number of participants with events.	7.6 months Interval 3.7 to Upper limit of confidence interval was not estimable due to low number of participants with events.	—

SECONDARY outcome

Timeframe: Up to 117 Weeks

OS is defined as time from date of dose initiation to death from any cause. KM estimates were used in outcome measure analysis.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=26 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=42 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=29 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) 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.
Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c)	7.6 months Interval 4.7 to 13.7	6.4 months Interval 3.9 to 8.3	9.8 months Interval 5.2 to Upper limit of confidence interval was not estimable due to low number of participants with events.	—

SECONDARY outcome

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

Population: 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. Here 'N' is defined as participants with available data at the given timepoint.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=23 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=23 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=7 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=36 Participants 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.
Serum Concentration of Magrolimab Day 253 Predose	363 μg/mL Standard Deviation 179	—	237 μg/mL Standard Deviation 56.6	—
Serum Concentration of Magrolimab Day 1 Predose	0 μg/mL Standard Deviation 0	0 μg/mL Standard Deviation 0	0 μg/mL Standard Deviation 0	0 μg/mL Standard Deviation 0
Serum Concentration of Magrolimab Day 8 Predose	0 μg/mL Standard Deviation 0	0 μg/mL Standard Deviation 0	0 μg/mL Standard Deviation 0	0 μg/mL Standard Deviation 0
Serum Concentration of Magrolimab Day 8 1-Hour Postdose	—	—	407 μg/mL Standard Deviation NA Standard Deviation (SD) is not estimable for 1 participant.	—
Serum Concentration of Magrolimab Day 22 Predose	302 μg/mL Standard Deviation 161	260 μg/mL Standard Deviation 148	460 μg/mL Standard Deviation 112	334 μg/mL Standard Deviation 134
Serum Concentration of Magrolimab Day 43 Predose	523 μg/mL Standard Deviation 195	439 μg/mL Standard Deviation 182	624 μg/mL Standard Deviation 451	529 μg/mL Standard Deviation 258
Serum Concentration of Magrolimab Day 43 1- Hour Postdose	1550 μg/mL Standard Deviation 525	1560 μg/mL Standard Deviation 492	1880 μg/mL Standard Deviation 523	1730 μg/mL Standard Deviation 560
Serum Concentration of Magrolimab Day 85 Predose	266 μg/mL Standard Deviation 134	319 μg/mL Standard Deviation 271	415 μg/mL Standard Deviation 135	297 μg/mL Standard Deviation 181
Serum Concentration of Magrolimab Day 127 Predose	281 μg/mL Standard Deviation 143	393 μg/mL Standard Deviation 93.8	277 μg/mL Standard Deviation 35.0	174 μg/mL Standard Deviation 106
Serum Concentration of Magrolimab Day 190 Predose	344 μg/mL Standard Deviation 104	—	281 μg/mL Standard Deviation 71.1	250 μg/mL Standard Deviation 113

SECONDARY outcome

Timeframe: Up to 113 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel) n=25 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=25 Participants 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.	Safety Run-in Cohort 1 (Magrolimab + Docetaxel) n=7 Participants 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.	Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel) n=37 Participants 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.
Percentage of Participants Who Developed Anti-Magrolimab Antibodies	4.0 percentage of participants	8.0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

Safety Run-in Cohort 1 (Magrolimab + Docetaxel)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 6 deaths

Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)

Serious events: 16 serious events

Other events: 29 other events

Deaths: 17 deaths

Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)

Serious events: 12 serious events

Other events: 26 other events

Deaths: 18 deaths

Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)

Serious events: 18 serious events

Other events: 41 other events

Deaths: 37 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER