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Monoclonal Antibodies

Axatilimab + Olaparib for Breast Cancer

Phase 1

Recruiting

Led By Filipa Lynce, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Age ≥18 years.

ECOG performance ≤ 2.

Must not have

Any previous treatment with CSF1R antibody.

Participants receiving medications or substances that are strong or moderate inhibitors or inducers of CYP450 enzyme(s) are ineligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and tolerance of a new drug called axatilimab when used together with olaparib, a standard treatment, in patients with specific types of breast cancer

Who is the study for?

This trial is for adults over 18 with HER2-negative metastatic breast cancer linked to BRCA1/2 or PALB2 mutations. They should have had no more than two prior chemotherapy treatments and must not be candidates for further endocrine therapy if their cancer is hormone receptor positive. Participants need a certain level of blood cells, liver function, and an ECOG performance score of ≤ 2.

What is being tested?

The study tests the safety and effectiveness of combining axatilimab (an antibody) with olaparib (a PARP inhibitor), which is already used in treating this type of breast cancer. Axatilimab is new, while olaparib represents standard care.

What are the potential side effects?

While specific side effects are not listed here, typical ones from antibodies like axatilimab may include allergic reactions or infusion-related issues. Olaparib can cause nausea, fatigue, blood cell count changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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

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My HIV is well-controlled with antiretroviral therapy.

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I am postmenopausal or have a negative pregnancy test.

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My blood tests for organ function are within the required range.

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I have a harmful mutation in BRCA1, BRCA2, or PALB2.

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I can swallow and keep down pills.

Exclusion Criteria

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

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I have never been treated with a CSF1R antibody.

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I am not taking strong or moderate drugs that affect liver enzymes.

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I have or might have a blood disorder related to MDS or AML.

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I have been diagnosed with active or latent tuberculosis.

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I cannot take pills by mouth or have a stomach condition that affects medication absorption.

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I have had pneumonitis or lung inflammation in the past.

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I do not have any uncontrolled illnesses or conditions that would stop me from following the study's requirements.

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I haven't had chemotherapy, immune therapy, or experimental treatments in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Median Progression Free Survival (PFS)

Objective Response Rate (ORR)

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: Axatilimab + OlaparibExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Axatilimab

2017

Completed Phase 1

~50