Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of Metastatic or Recurrent Breast or Castrate-Resistant Prostate Cancer With BRCA Mutations

Part of paid clinical trials in Costa Mesa, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05807126
Phase
PHASE1
Status
Withdrawn

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Castration-Resistant Prostate Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsies
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Magrolimab — BIOLOGICAL
    Given IV
  • Olaparib — DRUG
    Given PO

Study Details

This phase I/Ib trial studies the side effects and best dose of Hu5F9-G4 (magrolimab) when given in combination with olaparib for the treatment of patients with breast or castrate-resistant prostate cancer that have spread from where they first started (primary site) to other places in the body (metastatic) or have come back after a period of improvement (recurrent) and have mutations in the BRCA1/2 genes. Magrolimab is a monoclonal antibody with potential anticancer activity and the cability to stimulate the immune system and may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Combination therapy with magrolimab and olaparib may be safe and effective in treating BRCA-mutated metastatic or recurrent breast or castrate-resistant prostate cancer.

Key Dates

Start date
Mar 5, 2024
Status verified
Apr 2024
Primary completion
Dec 6, 2026
Completion
Dec 6, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (magrolimab, olaparib)
    Patients receive magrolimab IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of subsequent cycles. Patients also receive olaparib PO BID during each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT and/or MRI throughout the trial. Patients in the dose-expansion portion of the study also undergo tumor biopsies during screening and on study.

Primary Outcome Measure

Maximum tolerated dose (MTD) of olaparib with magrolimab (Dose Escalation) [ Time Frame: Up to 28 days after the beginning of the treatment cycle ]

Locations (5)

FacilityCityStateZIPSite coordinators
UC Irvine Health Cancer Center-NewportCosta MesaCalifornia92627-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Costa Mesa, CA

By research site
UC Irvine Health Cancer Center-Newport· Costa Mesa, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAMontefiore Medical Center - Moses Campus· The Bronx, NYMontefiore Medical Center-Einstein Campus· The Bronx, NYUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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