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)
M.D. Anderson Cancer Center
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.
Description
Primary Objective: 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. Secondary Objectives: 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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugCyclophosphamide
Given by mouth
- DrugAxatilimab (SNDX-6352)
Given by IV
- DrugRetifanlimab
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas