What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving monoclonal antibodies like magrolimab and PARP inhibitors like olaparib, have specific side effects. Monoclonal antibodies can cause immune-related side effects such as infusion reactions, fatigue, and potential autoimmune conditions. PARP inhibitors are associated with nausea, fatigue, anemia, thrombocytopenia, and neutropenia. Combining these treatments may result in overlapping toxicities, especially hematologic issues like anemia and neutropenia.

What prior FDA approvals exist?

For the treatment of prostate cancer, the FDA has approved several drugs that target similar mechanisms as Magrolimab and Olaparib. Pembrolizumab, a PD-1 inhibitor, is an immune checkpoint inhibitor approved for metastatic castration-resistant prostate cancer (CRPC) with specific genetic markers such as dMMR or high TMB. Olaparib, a PARP inhibitor, has shown efficacy in prostate cancer patients with BRCA1/2 mutations and is being evaluated in various clinical trials. These treatments focus on leveraging the immune system and targeting DNA repair mechanisms to combat tumor growth.

What other types of research exist?

Promising alternatives for prostate cancer treatment in 2024 include Pembrolizumab and Dostarlimab, which are immune checkpoint inhibitors targeting the PD-1 pathway, particularly effective in patients with dMMR or high TMB. Additionally, Niraparib, another PARP inhibitor, has shown efficacy in patients with BRCA mutations. Combining these with androgen receptor-targeted therapies like Enzalutamide or Abiraterone may also optimize outcomes.

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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

Must not have

Previous anti-CD47 therapy

Concomitant use of strong CYP3A4 inhibitors/inducers

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety and best dose of magrolimab combined with olaparib for patients with advanced breast or prostate cancer with BRCA1/2 mutations. Magrolimab helps the immune system attack cancer cells, and olaparib prevents these cells from repairing their DNA. Olaparib is taken orally and is used in treating BRCA1/2 mutated cancers, showing effectiveness in breast, ovarian, and prostate cancers.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received anti-CD47 therapy before.

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I am not taking strong CYP3A4 inhibitors or inducers.

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I have a stomach or intestine condition that affects how I take pills.

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I can follow the study plan and attend all required check-ups.

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I do not have any unmanaged ongoing illnesses.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Olaparib and magrolimab trough and potentially area under the curve

Tumor genomic markers

Other study objectives

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

Drug exposure and response and/or toxicity

Objective response rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2190

Biopsy

2014

Completed Phase 4

~1150

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

Magrolimab

2022

Completed Phase 2

~220

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen receptor inhibitors, chemotherapy, monoclonal antibodies, and PARP inhibitors. Androgen receptor inhibitors, such as enzalutamide, block the effects of androgens, which fuel prostate cancer growth. Chemotherapy, like docetaxel, kills rapidly dividing cancer cells. Monoclonal antibodies, such as Magrolimab, stimulate the immune system to target and destroy cancer cells while interfering with their growth and spread. PARP inhibitors, like Olaparib, prevent cancer cells from repairing their DNA, leading to cell death. These treatments are crucial as they target different aspects of cancer cell survival and proliferation, offering multiple avenues to control and potentially eradicate the disease.