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Monoclonal Antibodies

Magrolimab + Olaparib for Breast & Prostate Cancer

Phase 1

Waitlist Available

Led By Haider S Mahdi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of metastatic and/or recurrent solid tumors with pathogenic BRCA 1/2 mutated cancers where olaparib is indicated as standard of care therapeutic option

Metastatic castrate-resistant prostate cancer treatment after progressive disease on anti-androgens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre, c2d1, c3d1, c5d1, and at progression, assessed up to 36 months

Awards & highlights

Study Summary

This trial studies a combo of magrolimab & olaparib to treat BRCA-mutated cancer. Magrolimab stimulates the immune system & olaparib blocks DNA repair, helping tumor cells die.

Who is the study for?

This trial is for adults with metastatic or recurrent breast or castrate-resistant prostate cancer that have BRCA mutations. Candidates must not have had prior PARP inhibitors in the metastatic setting, no previous anti-CD47 therapy, and should be able to undergo biopsies. They need a stable heart function and cannot be on strong CYP3A4 drugs, immunosuppressants, or other investigational agents.Check my eligibility

What is being tested?

The trial tests combining Magrolimab (an immune-stimulating monoclonal antibody) with Olaparib (a PARP inhibitor that prevents tumor cells from repairing DNA damage). The goal is to determine the safety and optimal dosage of this combination treatment for patients with specific genetic mutations in their cancers.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system's stimulation by Magrolimab which could cause inflammation in various organs. Olaparib may lead to nausea, fatigue, anemia, blood clots, and other symptoms due to its interference with DNA repair in cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has BRCA 1/2 mutations and has spread or come back.

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My prostate cancer is spreading and not responding to hormone therapy.

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My BRCA mutation status was confirmed by a certified lab.

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I have not taken PARP inhibitors for advanced cancer treatment.

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I can take care of myself but might not be able to do active work.

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My brain metastases have been treated and are not getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre, c2d1, c3d1, c5d1, and at progression, assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre, c2d1, c3d1, c5d1, and at progression, assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre, c2d1, c3d1, c5d1, and at progression, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (Dose Expansion)

Maximum tolerated dose (MTD) of olaparib with magrolimab (Dose Escalation)

Recommended phase 2 dose (Dose Expansion)

+3 more

Secondary outcome measures

Olaparib and magrolimab trough and potentially area under the curve

Tumor genomic markers

Other outcome measures

Circulating tumor (ct)DNA assessment of BRCA and other genes

Drug exposure and response and/or toxicity

Objective response rate (ORR)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (magrolimab, olaparib)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2140

Magrolimab

2021

Completed Phase 2

~170

Biopsy

2014

Completed Phase 4

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,634 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 Patients Enrolled for Prostate Cancer

Haider S MahdiPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO

3 Previous Clinical Trials

226 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the use of magrolimab and olaparib likely to produce any adverse outcomes?

"Limited clinical data currently exists in regards to the safety and efficacy of Treatment (magrolimab, olaparib), thus a score of 1 was assigned."

Answered by AI

How many participants are currently being accepted into this medical experiment?

"Affirmative. Clinicaltrials.gov confirms that this research trial is actively enrolling and was initially announced on December 6th 2023 with the most recent update posted on September 6th 2023. The project requires 33 participants from one location to complete it."

Answered by AI

Is this research project open to new participants?

"Affirmative. The information on clinicaltrials.gov suggests that this experiment is currently open for recruitment, having been initially listed in December 6th 2023 and lastly updated on September 6th 2023. 33 patients need to be enrolled from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05807126.