Trial 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

• Status: Completed
• Trial end date: 2020-12-03
• Target enrollment: 0
• Participant gender: All

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 based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Eisenhauer 2009) 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forty Seven, Inc.; Gilead Sciences
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Antibodies, Monoclonal; Avelumab; Magrolimab

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 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.