A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs

Part of paid clinical trials in Duarte, California.

Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
Study ID
NCT06908928
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • bulumtatug fuvedotin — DRUG
    given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
  • bulumtatug fuvedotin — DRUG
    given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2

Study Details

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.

Key Dates

Start date
Aug 11, 2025
Status verified
Aug 2025
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level 1 of BFv
  • Experimental: Dose level 2 of BFv

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to approximately 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
877-460-2954
Hope Rugo (PRINCIPAL_INVESTIGATOR)
UCSD Moores Cancer CenterLa JollaCalifornia92093
866-773-2703
Rebecca Shatsky (PRINCIPAL_INVESTIGATOR)
Anschutz Medical CenterAuroraColorado80045-
UChicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
855-702-8222
Rita Nanda (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
646-888-6885
Nour Abuhadra (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
City of Hope· Duarte, CAUCSD Moores Cancer Center· La Jolla, CAAnschutz Medical Center· Aurora, COUChicago Medicine Comprehensive Cancer Center· Chicago, ILMassachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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