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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06959537
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