Actively Recruiting
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)
Led by M.D. Anderson Cancer Center · Updated on 2025-11-10
24
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic or locally recurrent unresectable malignancy without effective standard treatments
- Histologically or cytologically confirmed non-inflammatory triple negative breast cancer with ER <1%, PR <1%, and HER2 negative, or inflammatory breast cancer with ER <20% and PR <20%
- At least 1 week since prior chemotherapy or radiation therapy
- Age 18 years or older
- At least one measurable lesion per RECIST 1.1
- ECOG performance status 2 or better (Karnofsky score 60% or higher)
- Adequate organ and marrow function with specified blood counts and liver and kidney function
- Ability and willingness to sign informed consent
- Negative serum pregnancy test within 72 hours before first dose for women of childbearing potential
- Women of childbearing potential must use effective birth control methods or be surgically sterile or abstain from heterosexual activity during the study
- Men must agree to use adequate contraception during and for 4 months after the study
- Cognitive ability to participate in the study
You will not qualify if you...
- Unrecovered toxicities from prior anti-cancer therapy greater than Grade 1 except alopecia
- History of interstitial lung disease or active non-infectious pneumonitis
- Active autoimmune disease requiring systemic immunosuppression within 2 years before treatment
- Allergic reactions to study drugs or similar compounds
- Uncontrolled illnesses or serious physical or psychiatric conditions increasing study risks
- Active infections requiring systemic treatment within 14 days before treatment
- Known active Hepatitis B or C infection without control or cure
- Known HIV infection unless on effective therapy with undetectable viral load
- Psychiatric or social situations limiting compliance
- Pregnant women
- Cancer survivors except cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid cancer
- Active brain metastases requiring treatment; treated brain metastases must show no progression
- Known leptomeningeal disease
- Significant cardiac disease or abnormal screening ECG outside study criteria
- Significant cardiac events within 6 months before treatment
- Receiving other investigational agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Bora Lim, MD
CONTACT
A
Angela Alexander
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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