RecruitingPhase 1NCT06959537

A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)


Sponsor

M.D. Anderson Cancer Center

Enrollment

24 participants

Start Date

Aug 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical research study is to find the best dose of the drugs cyclophosphamide and axatilimab that can be given in combination with the standard dose of retifanlimab to patients with metastatic TNBC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — low-dose oral cyclophosphamide, axatilimab, and retifanlimab — in people with metastatic triple-negative breast cancer (TNBC), a type of breast cancer that lacks the three most common receptors and is harder to treat. The combination aims to break down the cancer's defense against the immune system. **You may be eligible if...** - You have been diagnosed with metastatic or locally recurrent triple-negative breast cancer (ER less than 1%, PR less than 1%, HER2 negative), including inflammatory breast cancer (IBC) with low hormone receptors - Your cancer has not responded to or cannot be treated with standard therapies - You are 18 or older with at least one measurable tumor on imaging - Your overall health (ECOG 0–2) and organ function are adequate **You may NOT be eligible if...** - You have received treatment in the past week (chemotherapy or radiation) - You have untreated cancer in the brain - You have active autoimmune disease or are on immune-suppressing medications - 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

DRUGCyclophosphamide

Given by mouth

DRUGAxatilimab (SNDX-6352)

Given by IV

DRUGRetifanlimab

Given by IV


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

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NCT06959537


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