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RecruitingInterventionalPhase 1

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

NCT ID: NCT06908928Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.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.

Arms & 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

Outcome measures

Primary

  • Objective Response Rate

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

    Time frame: Up to approximately 2 years

Secondary

  • Disease control rate

    Time frame: Up to approximately 2 years

  • Clinical benefit rate

    Time frame: Up to approximately 2 years

  • Duration of response

    Time frame: Up to approximately 2 years

  • Progression-free survival

    Time frame: Up to approximately 2 years

  • Overall survival

    Time frame: Up to approximately 2 years

  • Time to Maximum Concentration (Tmax)

    Time frame: Up to approximately 2 years

  • Maximum Concentration (Cmax)

    Time frame: Up to approximately 2 years

  • Half-life (t1/2)

    Time frame: Up to approximately 2 years

  • Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)

    Time frame: Up to approximately 2 years

  • Incidence, rate and severity of treatment-emergent adverse events.

    Time frame: Up to approximately 2 years

  • Immunogenicity

    Time frame: Up to approximately 2 years

  • Immunogenicity

    Time frame: Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria * 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 Criteria: * 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.

Study locations (6)

City of Hope

Duarte, California, 91010

Recruiting
· Contact
Hope Rugo · Principal Investigator

UCSD Moores Cancer Center

La Jolla, California, 92093

Recruiting
· Contact
Rebecca Shatsky · Principal Investigator

Anschutz Medical Center

Aurora, Colorado, 80045

Recruiting

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

Recruiting
· Contact
Rita Nanda · Principal Investigator

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Recruiting
· Contact
Nour Abuhadra · Principal Investigator