OVERVIEW
A Phase 1b Trial of Hu5F9-G4 in Combination With Avelumab in Solid Tumor Patients and Checkpoint-Inhibitor-Naive Ovarian Cancer Patients Who Progress Within 6 Months of Prior Platinum Chemotherapy
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Ovarian Cancer
Gender
N/A
Date
May 2018 - December 2020
Study Type
Interventional
Study Phase
Phase 1
Product
Magrolimab, Avelumab
Eligibility information
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.
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.
Locations
Locations (6)
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
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