RECRUITING

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

Conditions

Triple Negative Breast Cancer 9MW2821 bulumtatug fuvedotin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-11

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06908928

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

Fan Gao

CONTACT

+8615122736763

fan.gao@mabwell.com

Wenhui Zhang, MD

CONTACT

wenhui.zhang@mabwell.com

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

UCSD Moores Cancer Center

La Jolla, California, 92093

United States

UChicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11

Study Completion Date2028-05

Study Record Updates

Study Start Date2025-08-11

Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

9MW2821
bulumtatug fuvedotin

Additional Relevant MeSH Terms

Triple Negative Breast Cancer