RecruitingPhase 1NCT06908928

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


Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Enrollment

52 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of a drug called bulumtatug fuvedotin in women with triple-negative breast cancer (a type that doesn't respond to hormone therapies) who have already been treated with another antibody-drug conjugate medication. **You may be eligible if...** - You are 18 or older - You have metastatic or recurrent triple-negative breast cancer - You have already received a taxane (such as paclitaxel or docetaxel) and at least one prior antibody-drug conjugate with a topoisomerase inhibitor payload - You have had no more than 3 prior chemotherapy regimens for advanced disease - You are in good overall health (ECOG 0–1) with adequate organ function and a life expectancy of at least 3 months - You have a tumor that can be biopsied or archived tissue available **You may NOT be eligible if...** - You have received more than 3 prior lines of chemotherapy for advanced disease - Your organ function or overall health is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGbulumtatug fuvedotin

given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1

DRUGbulumtatug fuvedotin

given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2


Locations(6)

City of Hope

Duarte, California, United States

UCSD Moores Cancer Center

La Jolla, California, United States

Anschutz Medical Center

Aurora, Colorado, United States

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06908928


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