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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

LAST UPDATED

April 1, 2024

Clinicaltrials.gov ID

NCT03558139

STUDY DOCUMENTS

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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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

All

Healthy Icon

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

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.
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Exclusion

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.
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Locations

Locations (6)
Other

University of Chicago

Chicago, Illinois, United States, 60637

Other

START Midwest

Grand Rapids, Michigan, United States, 49546

Other

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Other

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75235

Other

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States, 78229

Other

University of Washington

Seattle, Washington, United States, 98109