Recruiting
Phase 1

Bulumtatug Fuvedotin

Sponsor:

Mabwell (Shanghai) Bioscience Co., Ltd.

Code:

NCT06908928

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

bulumtatug fuvedotin

bulumtatug fuvedotin

Study Details

Brief 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

Study ID

NCT06908928

Start date

Aug 11, 2025

Status verified date

Aug, 2025

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose level 1 of BFv

experimental: Dose level 2 of BFv

Interventions

bulumtatug fuvedotin

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

bulumtatug fuvedotin

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Fan Gao

+8615122736763fan.gao@mabwell.com

Wenhui Zhang, MD

wenhui.zhang@mabwell.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

877-460-2954

Principal Investigator:

Hope Rugo

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

866-773-2703

Principal Investigator:

Rebecca Shatsky

Anschutz Medical Center

Recruiting

Aurora, Colorado, United States, 80045

UChicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

855-702-8222

Principal Investigator:

Rita Nanda

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

646-888-6885

Principal Investigator:

Nour Abuhadra

More Information

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Last update posted

Mar 17, 2026

Last verified

Aug, 2025

Keywords

  • 9MW2821
  • bulumtatug fuvedotin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mabwell (Shanghai) Bioscience Co., Ltd. on 2026-03-17.