RecruitingPhase 1NCT06488378

Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer


Sponsor

Dana-Farber Cancer Institute

Enrollment

20 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — axatilimab (an immune-targeting drug) and olaparib (a PARP inhibitor that blocks DNA repair in cancer cells) — in people with advanced breast cancer that is HER2-negative and has a BRCA1, BRCA2, or PALB2 gene mutation. **You may be eligible if...** - You have metastatic or inoperable HER2-negative breast cancer (including HER2-low) - You have a confirmed BRCA1, BRCA2, or PALB2 gene mutation - Your hormone receptor-positive cancer has stopped responding to hormonal treatments - You have adequate organ function **You may NOT be eligible if...** - You have previously been treated with a PARP inhibitor (like olaparib or niraparib) - You have active brain metastases requiring treatment - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAxatilimab

Humanized immunoglobulin G (IgG)4 monoclonal antibody, 1.3 mL sterile, preservative free glass vials, via intravenous (into the vein) infusion per protocol.

DRUGOlaparib

Inhibitor of poly ADP ribose polymerase (PARP)1-3, 100 or 150 mg tablet, taken orally per standard of care.


Locations(3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06488378


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