Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies
This clinical study is evaluating a drug called BT7480 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression. The main goals of the study are to: * Find the recommended dose of BT7480 that can be given safely to participants alone and in combination with nivolumab * Learn about the side effects and effectiveness of BT7480 alone and in combination with nivolumab * Learn about the effect BT7480 has on the body and how BT7480 is cleared by the body * Learn about the side effects and effectiveness of BT7480 in patients with reduced kidney function
• Must have locally advanced or metastatic disease that is refractory to standard therapy, or for which no standard therapy is judged to be appropriate or provide clinical benefit, as judged by the Investigator
• Must have a histologically or cytologically confirmed malignant solid tumor associated with Nectin-4 expression, including, but not limited to, urothelial (transitional cell) carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; and ovarian, breast, gastric, or esophageal carcinoma
• Must have ECOG performance status score 0 or 1 and acceptable organ and hematological function
• Must have metastatic or locally advanced disease and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Life expectancy ≥12 weeks
• Must submit fresh or archival tumor tissue
• Must provide written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analysis