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

Phase 1

Not yet recruiting

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: bulumtatug fuvedotin

• Registration Number: NCT06908928
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Study Start: 2025-05
• Primary Completion: 2027-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level 1 of BFv	bulumtatug fuvedotin	-
Dose level 2 of BFv	bulumtatug fuvedotin	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	Up to approximately 2 years	Objective Response Rate according to RECIST v1.1 by investigator assessment

Secondary Outcome Measures

Name	Time	Method
Disease control rate	Up to approximately 2 years	The percentage of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST v1.1.
Clinical benefit rate	Up to approximately 2 years	The percentage of patients who achieve CR, PR, or SD for at least 6 months.
Duration of response	Up to approximately 2 years	The time from first documented response (CR or PR) to disease progression or death, whichever occurs first.
Progression-free survival	Up to approximately 2 years	The time from treatment initiation to disease progression or death from any cause.
Overall survival	Up to approximately 2 years	The time from treatment initiation to death from any cause.
Time to Maximum Concentration (Tmax)	Up to approximately 2 years	Time to reach the maximum observed concentration of bulumtatug fuvedotin, TAb, and MMAE in blood.
Maximum Concentration (Cmax)	Up to approximately 2 years	Maximum observed blood concentration of bulumtatug fuvedotin, TAb, and MMAE.
Half-life (t1/2)	Up to approximately 2 years	The time required for the blood concentration of bulumtatug fuvedotin, TAb, and MMAE to decrease by 50%.
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)	Up to approximately 2 years	The area under the plasma concentration-time curve from time zero to the last measurable concentration for bulumtatug fuvedotin, TAb, and MMAE.
Incidence, rate and severity of treatment-emergent adverse events.	Up to approximately 2 years	Incidence, rate and severity of AE, SAE, TRAE and AESI. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record. Safety will be reported as incidence and rate of treatment-emergent adverse events using NCI CTCAE v5.0 criteria.
Immunogenicity	Up to approximately 2 years	Titre of ADA and Nab.