Phase 1
Completed N=34
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
Source: ClinicalTrials.gov NCT03558139 ↗Enrolled (actual)
34
Serious AEs
50.0%
Results posted
Apr 2024
Primary outcomePrimary: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Safety Run-in (Part 1) — 0; 0 percentage of participants
Summary
The primary objectives of this study are to investigate the safety and tolerability of magrolimab in combination with avelumab in participants with advanced solid tumors and to confirm the safety and tolerability of this combination and evaluate the anti-tumor activity in participants with checkpoint inhibitor-naive ovarian cancer, fallopian tube cancer, and primary peritoneal carcinoma who have previously progressed within 1-6 months of receiving platinum chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Safety Run-in (Part 1) |
0; 0 | — |
| PRIMARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
100; 100; 100 | — |
| PRIMARY 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 | — |
| SECONDARY Recommended Phase 2 Dose and Schedule (RP2DS) of Magrolimab in Combination With Avelumab |
45 | — |
| SECONDARY Serum Concentrations of Magrolimab - Safety Run-in (Part 1) |
0.00; 0.00; 0.76; 0.62; 0.06; 0.04 | — |
| SECONDARY Percentage of Participants With Transient Anti-Drug Antibody to Magrolimab - Safety Run-in (Part 1) |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Objective Response According to Gynecologic Cancer InterGroup (GCIG) Criteria in Ovarian Cancer |
4.8 | — |
| SECONDARY Duration of Response (DOR) as Per GCIG Criteria in Participants With Ovarian Cancer |
— | — |
| SECONDARY Progression-free Survival (PFS) in Participants With Ovarian Cancer |
2.0 | — |
| SECONDARY Overall Survival (OS) in Participants With Ovarian Cancer |
10.2 | — |
| SECONDARY Percent Change of Immune Cells by Immunohistochemistry in Participants With Ovarian Cancer |
137.8 | — |
Eligibility Criteria
Key Inclusion Criteria
- Safety Run-in Cohort: Pathologically confirmed advanced solid tumors.
- Ovarian Cancer Expansion Cohort: Histologically or cytologically confirmed, epithelial ovarian, fallopian tube, or peritoneal cancer.
- Checkpoint inhibitor naive participants.
- Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy.
- Adequate performance status. Adequate hematological, liver, and kidney functions.
- Availability of pre-treatment tumor tissue to evaluate programmed cell death-ligand 1(PD-L1) expression.
Key Exclusion Criteria
- Individuals with symptomatic or untreated central nervous system (CNS) metastases.
- Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents.
- Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV).
- Red blood cell transfusion dependence.
- Prior organ transplantation requiring immunosuppression or active autoimmune disease.
- Significant medical diseases and/or history of uncontrolled intercurrent illness or other serious medical condition.
- Pregnancy or active breast feeding.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03558139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.