NCT06908928

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

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2025-04-03
• Last updated: 2026-03-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study