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
- Brief Title: A Trial of Hu5F9-G4 With Avelumab in Ovarian Cancer
- Official Title: A Phase 1b Trial of Hu5F9-G4 in Combination With Avelumab in Solid Tumor Patients and Checkpoint Inhibitor Naïve Ovarian Cancer Patients Who Progress Within 6 Months of Prior Platinum Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
- NCT ID:
- Solid Tumor
- Ovarian Cancer
This is an open label, multicenter, Phase 1b trial investigating the combination of Hu5F9 G4
and avelumab in patients with solid tumors and ovarian cancer.
|Treatment||Experimental||Combination of Hu5F9-G4 and avelumab.|
- Safety Run-in: Pathologically confirmed advanced solid tumors.
- Ovarian Cancer Expansion: Histologically or cytologically confirmed, epithelial
ovarian, fallopian tube, or peritoneal cancer.
- Ovarian Cancer Expansion: Checkpoint inhibitor naïve patients.
- Ovarian Cancer Expansion: 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 tisse to evaulate PD-L1 expression.
- Patients with symptomatic or untreated central nervous system (CNS) metastases.
- Prior treatment with CD47 or SIRPα targeting agents.
- Known active or chronic hepatitis B or C infection or human immunodeficiency virus
- RBC 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.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|
Primary Outcome Measures
|Description:||Number of participants with dose-limiting toxicities and treatment-related adverse events as assessed by CTCAE v4.03.|
|Lead Sponsor:||Forty Seven, Inc.|