Status:
RECRUITING
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Triple Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06908928
Start Date
August 11 2025
End Date
May 1 2028
Last Update
September 23 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope
Duarte, California, United States, 91010
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
3
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021