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)
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 breast-cancer
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 6, 2025
CompletedStudy Start
First participant enrolled
August 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
November 10, 2025
November 1, 2025
1.5 years
April 28, 2025
November 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year
Study Arms (1)
Treatment with Cyclophosphamide + Axatilimab + Retifanlimab
EXPERIMENTALParticipants will be requestd to maintain a medication diary of each dose of medication while taking oral cyclophosphamide. The medication diary will be returned to clinic staff at the end of each course.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed malignancy that is metastatic or locally recurrent unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Patients must have histologically or cytologically confirmed non-IBC triple negative breast cancers, defined here as ER\<1%, PR\<1% and HER2 negative per ASCO CAP 2018 guideline. OR
- Inflammatory breast cancer (IBC) confirmed according to international consensus criteria that is ER\<20% and PR\<20%.
- At least 1 week since prior chemotherapy or radiation therapy
- Age .18 years.
- Has at least one measurable lesion per RECIST 1.1
- ECOG performance status . 2 (Karnofsky . 60%,).
- Patients must have adequate organ and marrow function as defined below:
- absolute neutrophil count . 1,000/mcL
- hemoglobin \>9 mg/dL
- platelets . 100,000/mcL
- total bilirubin . institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) . 3 \~ institutional ULN; . 5 \~ institutional ULN if confirmed liver metastasis and elevation is deemed to be directly due to metastasis.
- Creatinine clearance .30 mL/min (measured by the Cockcroft-Gault equation\*).
- Ability to understand and the willingness to sign a written informed consent
- +8 more criteria
You may not qualify if:
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) except for alopecia. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \> Grade 2 for at least 3 months prior to \[enrollment/Cycle 1 Day 1\] and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, including: Chemotherapyinduced neuropathy, Fatigue, Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism, Type I diabetes, Hyperglycemia, Adrenal insufficiency, Adrenalitis and Skin hypopigmentation (vitiligo)
- Patients with a history of interstitial lung disease (past or current) or active, non-infectious pneumonitis.
- Patients with active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, axatilimab, retifanlimab used in study.
- Patients with uncontrolled intercurrent illness. Medical history or complication considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study in the investigator's opinion.
- Patients with active infections requiring systemic antibiotics or antifungal or antiviral treatment within 14 days of C1D1 study treatment.
- Patients with known active Hepatitis B or Hepatitis C infection. Testing is required to establish eligibility. Active Hepatitis B infection is defined as a positive Hepatitis B surface antigen and positive Hepatitis B core antibody test. Active Hepatitis C infection is defined assay.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
- For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with known HIV infection, defined as positive for HIV1/2 antibodies. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study due to potential for teratogenic or abortifacient effects.
- Patients who are cancer survivors other than cured non-melanomatous skin cancer or cured cervical carcinoma in situ and thyroid cancer will be excluded from the study as other cancers can recur.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bora Lim, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 6, 2025
Study Start
August 13, 2025
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2029
Last Updated
November 10, 2025
Record last verified: 2025-11