Clinical Trials /

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

NCT03558139

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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: 5F9006
  • NCT ID: NCT03558139

Conditions

  • Solid Tumor
  • Ovarian Cancer

Interventions

DrugSynonymsArms
Hu5F9-G4Treatment
AvelumabTreatment

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TreatmentExperimentalCombination of Hu5F9-G4 and avelumab.
  • Hu5F9-G4
  • Avelumab

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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
             (HIV).

          -  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
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-Limiting Toxicities
Time Frame:35-Days
Safety Issue:
Description:Number of participants with dose-limiting toxicities and treatment-related adverse events as assessed by CTCAE v4.03.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Forty Seven, Inc.

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