Trial Outcomes & Findings for Study of Magrolimab (Hu5F9-G4) in Combination With Avelumab in Solid Tumor Participants and Checkpoint-Inhibitor-Naive Ovarian Cancer Participants Who Progress Within 6 Months of Prior Platinum Chemotherapy (NCT NCT03558139)

Last Updated: 2024-04-01

Results Overview

A DLT was defined as a ≥ Grade 3 AE that was assessed as related to either magrolimab or avelumab that occurred during the 5-week DLT assessment period with protocol-defined allowed exceptions. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

From the first dose date up to 5 weeks

Results posted on

2024-04-01

Participant Flow

Participants were enrolled at study sites in the United States. The first participant was screened on 23 May 2018. The last study visit occurred on 03 December 2020.

43 participants were screened.

Participant milestones

Participant milestones
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab intravenous (IV) infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 2, Ovarian Cancer Expansion) Participants with checkpoint inhibitor-naïve ovarian cancer were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.
Overall Study STARTED	6	7	21
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	7	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab intravenous (IV) infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 2, Ovarian Cancer Expansion) Participants with checkpoint inhibitor-naïve ovarian cancer were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.
Overall Study Consent Withdrawn	1	1	4
Overall Study Death	5	3	8
Overall Study Lost to Follow-up	0	0	3
Overall Study Study Ended Per Protocol	0	3	6

Baseline Characteristics

The data for mean baseline CD68 macrophage was not collected for participants in Part 1, Safety Run-in Cohorts. Data are reported for the participants who enrolled in Ovarian Cancer Expansion Cohort (Part 2) and for whom paired biopsies were available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=6 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=7 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 2, Ovarian Cancer Expansion) n=21 Participants Participants with checkpoint inhibitor-naïve ovarian cancer were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Total n=34 Participants Total of all reporting groups
Age, Continuous	65.2 years STANDARD_DEVIATION 14.34 • n=6 Participants	65.3 years STANDARD_DEVIATION 7.48 • n=7 Participants	64.5 years STANDARD_DEVIATION 5.59 • n=21 Participants	64.8 years STANDARD_DEVIATION 7.77 • n=34 Participants
Sex: Female, Male Female	4 Participants n=6 Participants	4 Participants n=7 Participants	21 Participants n=21 Participants	29 Participants n=34 Participants
Sex: Female, Male Male	2 Participants n=6 Participants	3 Participants n=7 Participants	0 Participants n=21 Participants	5 Participants n=34 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=6 Participants	0 Participants n=7 Participants	1 Participants n=21 Participants	2 Participants n=34 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=6 Participants	7 Participants n=7 Participants	18 Participants n=21 Participants	30 Participants n=34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=7 Participants	2 Participants n=21 Participants	2 Participants n=34 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=21 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=21 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=21 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=21 Participants	0 Participants n=34 Participants
Race (NIH/OMB) White	6 Participants n=6 Participants	7 Participants n=7 Participants	20 Participants n=21 Participants	33 Participants n=34 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=21 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	0 Participants n=7 Participants	1 Participants n=21 Participants	1 Participants n=34 Participants
CD68 Macrophages	—	—	6.3 cells n=6 Participants • The data for mean baseline CD68 macrophage was not collected for participants in Part 1, Safety Run-in Cohorts. Data are reported for the participants who enrolled in Ovarian Cancer Expansion Cohort (Part 2) and for whom paired biopsies were available.	6.3 cells n=6 Participants • The data for mean baseline CD68 macrophage was not collected for participants in Part 1, Safety Run-in Cohorts. Data are reported for the participants who enrolled in Ovarian Cancer Expansion Cohort (Part 2) and for whom paired biopsies were available.

PRIMARY outcome

Timeframe: From the first dose date up to 5 weeks

Population: DLT evaluable participants: Participants in the Safety Run-in Part who met if either of the following criteria during the DLT assessment period: * the participant experienced a DLT at any time after initiation of the first infusion of either magrolimab or avelumab and during the 5-week DLT assessment period * the participant completed at least 4 (or 5 if assigned to magrolimab 45 mg/kg + avelumab 800 mg) infusions of magrolimab at the assigned dose and 2 infusions of avelumab.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=6 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=6 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Safety Run-in (Part 1)	0 percentage of participants	0 percentage of participants	—

PRIMARY outcome

Timeframe: First dose date up to last dose plus 30 days (maximum treatment duration 18.3 months)

Population: All Treated participants (included all participants who received at least 1 dose of any study drugs) were analyzed. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level. One participant in Part 2 received maintenance dose of 20 mg/kg. Because of confidentiality reason, data for this participant was not provided separately and included in "Magrolimab Priming Dose or Magrolimab 20 mg/kg" arm.

An AE was 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. Treatment-emergent AEs were defined as those AEs that worsened or occurred during or after a participant's first dose of any study treatment and those existing AEs that worsened during the study and within 30 days after the last administration of any study treatment or initiation of subsequent anticancer therapy, whichever occurred first.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=6 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=25 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg n=3 Participants Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	100 percentage of participants	100 percentage of participants	100 percentage of participants

PRIMARY outcome

Timeframe: From screening until 26.2 months (assessed on Day 1 of Cycle 3 then every 2 cycles from Cycle 5 onwards up to 26.2 months; 1 cycle: 28 days)

Population: Efficacy Analysis Set included checkpoint inhibitor-naive participants with ovarian cancer, who had previously progressed within 6 months of receiving platinum chemotherapy and received at least one dose of magrolimab during this study.

Objective response was defined as the percentage of participants with objective response which consisted of complete response (CR)+ partial response (PR) determined by RECIST v 1.1. CR: Disappearance of all target and all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=21 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Percentage of Participants With Objective Response (ORR) Assessed by Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 in Participants With Ovarian Cancer	0.0 percentage of participants Interval 0.0 to 16.8	—	—

SECONDARY outcome

Timeframe: From the first dose date up to 5 weeks

Population: All Treated participants in Part 1 were analyzed.

The RP2DS was the dose of magrolimab in combination with avelumab with DLT rate less than 33% in at least 6 evaluable participants in Part 1. A DLT was defined as a ≥ Grade 3 AE that was assessed as related to either magrolimab or avelumab that occurred during the 5-week DLT assessment period with protocol-defined allowed exceptions. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=13 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Recommended Phase 2 Dose and Schedule (RP2DS) of Magrolimab in Combination With Avelumab	45 mg/kg	—	—

SECONDARY outcome

Timeframe: Predose: (C1D1, C1D22, C2D1,C2D15, C3D1, C4D1, C5D1 [only for 45 mg/kg Part 1], C7D1, C10D1, C11D1 [only for 45 mg/kg Part 1], C13D1, EOT, Safety Follow-up); 1 hour postdose: (C1D1, C1D8); 24 hours postdose: (C1D1, C1D8)

Population: Pharmacokinetic Analysis Set (included participants who received any amount of magrolimab with at least one detectable post-treatment serum concentration of magrolimab) with available data in Part 1 were analyzed.

Serum concentrations will be drawn at pre-study drug infusion (within 12 hours) on Day (D) 1 and 22 in Cycle (C) 1; Days 1 and 15 in Cycle 2; Day 1 in Cycles 3 and 4; every 3rd cycle on Day 1 until Cycle 13; 1 hour post-magrolimab infusion on Days 1 and 8 in Cycle 1; 24 hours post magrolimab infusion (Part 1 only) on Days 1 and 8 in Cycle 1; pre-study drug infusion on Day 1 in Cycles 5 and 11 (Part 1 Magrolimab 45 mg/kg only); End of Treatment (EOT) visit (up to Cycle 13); Safety Follow-up Visit (30 days after last dose of magrolimab, maximum treatment duration 18.3 months). Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=6 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=7 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on EOT	418.00 ug/mL	731.00 ug/mL	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Safety Follow-up	101.93 ug/mL Standard Deviation 52.851	281.28 ug/mL Standard Deviation 241.454	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 1	0.00 ug/mL Standard Deviation 0.000	0.00 ug/mL Standard Deviation 0.000	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) 1 hour post-magrolimab dose on Day 1 Cycle 1	0.76 ug/mL Standard Deviation 0.544	0.62 ug/mL Standard Deviation 0.583	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) 24 hours post-magrolimab dose on Day 1 Cycle 1	0.06 ug/mL Standard Deviation 0.139	0.04 ug/mL Standard Deviation 0.104	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) 1 hour post-magrolimab dose on Day 8 Cycle 1	925.83 ug/mL Standard Deviation 171.835	981.43 ug/mL Standard Deviation 249.861	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) 24 hours post-magrolimab dose on Day 8 Cycle 1	487.80 ug/mL Standard Deviation 108.493	680.57 ug/mL Standard Deviation 128.439	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 22 Cycle 1	403.50 ug/mL Standard Deviation 65.145	769.57 ug/mL Standard Deviation 209.417	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 2	840.00 ug/mL Standard Deviation 155.259	867.57 ug/mL Standard Deviation 232.251	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 15 Cycle 2	447.20 ug/mL Standard Deviation 72.116	915.57 ug/mL Standard Deviation 295.178	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 3	458.20 ug/mL Standard Deviation 103.355	1175.00 ug/mL Standard Deviation 117.331	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 4	427.50 ug/mL Standard Deviation 83.636	678.50 ug/mL Standard Deviation 251.023	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 5	—	819.00 ug/mL	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 7	243.00 ug/mL	621.50 ug/mL Standard Deviation 256.680	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 10	334.00 ug/mL	759.00 ug/mL	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 11	—	770.00 ug/mL	—
Serum Concentrations of Magrolimab - Safety Run-in (Part 1) Pre-dose on Day 1 Cycle 13	267.00 ug/mL	807.00 ug/mL	—

SECONDARY outcome

Timeframe: From Day 1 of Cycle 1 up to Safety Follow-up (30 days after last dose of magrolimab, maximum treatment duration 18.3 months); Cycle 1: 35 days, subsequent Cycles: 28 days.

Population: Immunogenicity Analysis Set included participants with at least one reported Anti-Drug Antibody result.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=6 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=7 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Percentage of Participants With Transient Anti-Drug Antibody to Magrolimab - Safety Run-in (Part 1)	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: From Screening until 26.2 months (assessed on Day 1 of Cycle 3 then every 2 cycles from Cycle 5 onwards up to 26.2 months; 1 cycle: 28 days)

Population: Participants in the Efficacy Analysis Set were analyzed.

Objective response was defined as participants with a CR or a PR as assessed per GCIG criteria. The GCIG proposed use of both the RECIST and cancer antigen 125 (CA-125) criteria. A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Participants can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the upper limit of normal (ULN) and within 2 weeks prior to starting treatment. According to RECIST 1.1, CR was defined as disappearance of all target and all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). Any pathological lymph nodes (whether target or non-target) had a 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 baseline sum diameters.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=21 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Percentage of Participants With Objective Response According to Gynecologic Cancer InterGroup (GCIG) Criteria in Ovarian Cancer	4.8 percentage of participants Interval 0.1 to 23.8	—	—

SECONDARY outcome

Timeframe: From initial response until disease progression or maximum time on study (26.2 months); assessed on Day 1 of Cycle 3 then every 2 cycles from Cycle 5 onwards up to 26.2 months; 1 cycle: 28 days

Population: Participants in the Efficacy Analysis Set who achieved objective response according to GCIG criteria. Only 1 participant was analyzed for this Outcome Measure. Data is not reported for participant confidentiality reasons.

DOR: time from initial response (CR or PR) until disease progression. Disease progression was defined according to RECIST 1.1 but can also be based on serum CA-125. Progression based on serum CA-125 levels was defined as (1) elevated CA-125 pretreatment and normalization of CA-125 with evidence of CA-125 ≥2x ULN on 2 occasions at least 1 week apart or; (2) elevated CA-125 pretreatment, which never normalizes, with evidence of CA-125 ≥2x nadir value on 2 occasions at least 1 week apart or; (3) CA-125 in normal range pretreatment with evidence of CA-125 ≥2x ULN on 2 occasions at least 1 week apart. Progression per RECIST 1.1: At least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum measured while on study (this included baseline sum if that was smallest). In addition to relative increase of 20%, sum must also demonstrate absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose date to disease progression, death or maximum time on study (26.2 months); assessed on Day 1 of Cycle 3 then every 2 cycles from Cycle 5 onwards up to 26.2 months; 1 cycle: 28 days

Population: Participants in the Efficacy Analysis Set were analyzed.

PFS was defined as the duration of time from dose initiation to the first date of objectively documented disease progression per RECIST 1.1 or death, whichever occurred at first. Progression as per RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was 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. Unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=21 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Progression-free Survival (PFS) in Participants With Ovarian Cancer	2.0 months Interval 1.9 to 4.0	—	—

SECONDARY outcome

Timeframe: From first dose date to death or maximum time on study (26.2 months)

Population: Participants in the Efficacy Analysis Set were analyzed

OS was defined as the duration of time from dose initiation to the date of death due to any cause. Participants who did not die were censored at their last known alive date. Kaplan-Meier estimate was used for analysis.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=21 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Overall Survival (OS) in Participants With Ovarian Cancer	10.2 months Interval 2.1 to Upper limit of 95% confidence interval was not reached due to the low number of participants with events.	—	—

SECONDARY outcome

Timeframe: Screening and Day 1 Cycle 3 (Cycle 3 duration: 28 days)

Population: Participants who enrolled in ovarian cancer expansion cohort (Part 2) and for whom paired biopsies were available at both screening and Cycle 3 Day 1 were analyzed.

Paired tumor biopsies from participants with ovarian cancer were analyzed by CD68 immunohistochemistry staining to evaluate the impact of magrolimab in combination with avelumab on macrophage frequency in the tumor microenvironment.

Outcome measures

Outcome measures
Measure	Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) n=6 Participants Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 30 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 15, 22, and 29 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in) Participants with solid tumors were treated with starting priming dose of 1 mg/kg of body weight magrolimab IV infusion (over 3 hours) on Day 1 of Cycle 1 followed by maintenance dose of 45 mg/kg of body weight magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, 22, and 29 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles, in combination with 800 mg avelumab IV infusion (over 1 hour) on Days 8 and 22 of Cycle 1 and Days 1 and 15 of Cycle 2 and subsequent cycles. Cycle 1 consisted of 35 days and Cycle 2 and subsequent cycle consisted of 28 days. Avelumab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until confirmed tumor progression, unacceptable toxicity, clinically significant change in the participant's status that precluded further treatment, voluntary withdrawal, or physician decision.	Magrolimab Priming Dose or Magrolimab 20 mg/kg Participants who received only priming dose of magrolimab (1 mg/kg) in Part 2 of the study. For 1 participant (Part 2) magrolimab infusion was not completed at the first maintenance dose because of adverse event and \<60% of planned dose was administered. Subsequently the participant was treated at 20 mg/kg dose level.
Percent Change of Immune Cells by Immunohistochemistry in Participants With Ovarian Cancer	137.8 Percent Change Interval -66.67 to 700.0	—	—

Adverse Events

Magrolimab 30 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 5 deaths

Magrolimab 45 mg/kg + Avelumab 800 mg (Part 1, Safety Run-in + Part 2, Ovarian Cancer Expansion)

Serious events: 15 serious events

Other events: 25 other events

Deaths: 10 deaths

Magrolimab Priming Dose or Magrolimab 20 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 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