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Bulumtatug Fuvedotin for Triple Negative Breast Cancer

This study is looking at bulumtatug fuvedotin in people with triple-negative breast cancer that has come back or spread (recurrent or metastatic). You might be able to join if you've already been treated with a taxane and a type of drug called an antibody-drug conjugate (ADC) that uses a topoisomerase inhibitor. The study will give bulumtatug fuvedotin through an IV on two specific days every three weeks. Researchers want to see how many patients respond to the treatment. The study is currently unclear about its recruitment status and plans to enroll 52 participants.

Study design
This is an interventional study with 52 planned participants. It is testing two different dose levels of bulumtatug fuvedotin.
What's involved
You would receive bulumtatug fuvedotin through an IV on day 1 and day 8 of every 21-day cycle.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06908928

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mabwell (Shanghai) Bioscience Co., Ltd.
~52 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:bulumtatug fuvedotin

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate
Measured over Up to approximately 2 years

Conditions

Triple Negative Breast Cancer

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Triple-negative breast cancer

NCT06908928

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • UChicago Medicine Comprehensive Cancer Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • UCSD Moores Cancer Center

    La Jolla, Californiastudy coordinator listed

    Recruiting

  • Anschutz Medical Center

    Aurora, Coloradono site contact published

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Fan Gao
[email protected]
+8615122736763
Email the study team

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Eligibility criteria

Inclusion

Patient has measurable disease by RECIST v1.1
Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines
Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload.
Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
Provision of archival tumor tissue or fresh tumor biopsy.
Capable of giving informed consent
Male or female subjects aged ≥ 18 years.
Subjects must be willing to receive blood transfusions if medically indicated.
ECOG 0-1
Adequate hematologic and organ function
Life expectancy of at least 3 months as assessed by the investigator
Compliance with contraceptive requirement

Exclusion

Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.
Unstable CNS metastasis requiring treatment in the last 28 days.
Acute infection requiring IV treatment in the last 14 days.
Grade ≥2 peripheral neuropathy.
Pregnant or breastfeeding women.
Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk
Any systemic anticancer therapy in the last 28 days prior to first administration of study drug.
Active HCV, HBV or HIV infection unless well controlled with anti-viral therapy.
Active or chronic corneal disorder, keratitis, corneal ulcerations or Sjogren's syndrome.
Have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled.
Have been diagnosed with another primary malignancy except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or subjects with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
Have significant, uncontrolled or active cardiovascular disease
Have active or a history of pneumonitis or interstitial lung disease that requires corticosteroid treatment. Patients with radiation pneumonitis that does not require treatment is allowed.
Have uncontrolled diabetes.
Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.
Subjects known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation.
History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
Have received a live vaccine within 30 days of planned start of study therapy.

What this trial measures

  • Objective Response RateUp to approximately 2 years

    Objective Response Rate according to RECIST v1.1 by investigator assessment