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.
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.
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.
Parallel
bulumtatug fuvedotin
Druggiven via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
bulumtatug fuvedotin
Druggiven via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2
Objective Response Rate
Objective Response Rate according to RECIST v1.1 by investigator assessment
Disease control rate
The percentage of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST v1.1.
Clinical benefit rate
The percentage of patients who achieve CR, PR, or SD for at least 6 months.
Duration of response
The time from first documented response (CR or PR) to disease progression or death, whichever occurs first.
Progression-free survival
The time from treatment initiation to disease progression or death from any cause.
Efficacy parameters and biomarkers including but not limited to nectin-4 expression level.
The proportion of nectin-4 positive and negative patients. The proportion of nectin-4 positive patients who experienced objective response. The proportion of nectin-4 negative patients who experienced objective response.
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