A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
NCT06908928 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2026-03-17
Summary
The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.
Conditions
Interventions
- DRUG
-
bulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
- DRUG
-
bulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2
Sponsors & Collaborators
-
Mabwell (Shanghai) Bioscience Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-11
- Primary Completion
- 2027-05-31
- Completion
- 2028-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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