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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06488378
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

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

Interventions

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

Study Details

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)

Key Dates

Start date
Aug 13, 2024
Status verified
Aug 2025
Primary completion
Sep 1, 2026
Completion
Mar 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Axatilimab + Olaparib
    A Bayesian Optimal Interval design will be used to establish the maximum tolerated dose of Axatilimab. Dose reduction and escalation will be per protocol. Participants will complete: * Baseline visit, tumor biopsy, and imaging * Imaging every 8 weeks * Window Phase: --Predetermined dose of Olaparib 2x daily, taken 12 hours apart for 14 days * Combination Treatment Phase: * Cycle 1 through Cycle 2: * Day 1 of 28 day cycle: Tumor biopsy * Days 1 and 15 of 28 day Cycle: Predetermined dose of Axalitimab 1x daily * Days 1 through 28 of 28 day cycle Predetermined dose of Olaparib 2x daily, 12 hours apart * Tumor biopsy after two weeks of Olaparib and at the end of Cycle 2 * Cycle 3 through End of Treatment: * Days 1 and 15 of 28 Day Cycle: Predetermined dose of Axalitimab 1x daily * Predetermined dose of Olaparib 2x daily, taken 12 hours apart * End of Treatment Visit with imaging * Follow Up: Every 6 months for 3 years. Imaging will be every 10 weeks.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Nadine Tung, MD
[email protected]
Brigham and Women's HospitalBostonMassachusetts02215
Filipa Lynce, MD
[email protected]
617-632-2335
Filipa Lynce, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Filipa Lynce, MD
[email protected]
617-632-2335
Filipa Lynce, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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