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)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06959537
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given by mouth
  • Axatilimab (SNDX-6352) — DRUG
    Given by IV
  • Retifanlimab — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
Aug 13, 2025
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Cyclophosphamide + Axatilimab + Retifanlimab
    Participants 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.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Bora Lim, MD
[email protected]
713-745-0689
Angela Alexander
832-450-5265
Bora Lim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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