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)

StatusSuspended
PhasePhase 1
Started

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Record History

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  1. Recruitment suspended Sponsor's reason: PI Request
    • Eligibility criteria expanded, about 44 words
    • Site details revised
  2. 2 versions Re-verified since May 18, 2026, no change to tracked fieldsv5-v6
  3. Phase: Phase 1/2 to Phase 1
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2025 to Aug 13, 2025
    • Site details revised
    v4
  4. Site contact updated
    • Study title revised
    v3
  5. Site contact updatedv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06959537
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov