NCT06488378

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a non-randomized, open-label, proof-of-concept phase 1 study to evaluate the safety and tolerability of a drug known as Axatilimab in combination with the drug Olaparib in BRCA1/2 and PALB2 associated HER2-negative breast cancer. The U.S. Food and Drug Administration (FDA) has not approved axatilimab as a treatment for any disease. The FDA has approved olaparib as a treatment option for BRCA1/2 and PALB2 associated HER2-negative breast cancer, and it is considered standard of care for those types of breast cancer. The FDA has approved olaparib for metastatic (breast cancer that has spread) BRCA1/2 associated HER2-negative breast cancer. The research study procedures include screening for eligibility, study treatment in-clinic visits, tumor biopsies, blood tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, and electrocardiograms. Participation in this research study is expected to last for as long as there is clinical benefit and participants will be followed for a maximum of three years after finishing study treatment. It is expected that about 16-20 people will take part in this research study. Incyte Corporation is funding this research study and providing Axatilimab.

Conditions

• Breast Cancer
• PALB2-Mutated Breast Carcinoma
• HER2-negative Breast Cancer
• BRCA1 Mutation
• BRCA2 Mutation

Interventions

Type	Name	Description
DRUG	Axatilimab	Humanized immunoglobulin G (IgG)4 monoclonal antibody, 1.3 mL sterile, preservative free glass vials, via intravenous (into the vein) infusion per protocol.
DRUG	Olaparib	Inhibitor of poly ADP ribose polymerase (PARP)1-3, 100 or 150 mg tablet, taken orally per standard of care.

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-09-01
• Completion: 2029-03-01
• First posted: 2024-07-05
• Last updated: 2025-08-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study