Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies
This clinical trial is evaluating a drug called BT8009 alone and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The main goals of this study are to: - Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with pembrolizumab - Learn more about the side effects and effectiveness of BT8009 alone and in combination with pembrolizumab - Learn more about BT8009 alone and in combination with pembrolizumab - Learn more about BT8009 alone in patients with renal insufficiency
BT8009 consists of a bicyclic peptide (Bicycle®) which binds selectively to Nectin-4 covalently attached to a spacer and a val-cit cleavable linker attached to a cytotoxin (MMAE). This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent in 3 different dosing schedules- weekly (28 day cycle), biweekly (28 day cycle) , dosing on day 1 and day 8 of a 3-weekly cycle and in combination with pembrolizumab. There are three parts to this study. Part A is a dose escalation in patients with select advanced solid tumors primarily designed to evaluate safety and tolerability of BT8009 as monotherapy or in combination with pembrolizumab and to determine a recommended Phase II dose (RP2D). Following a selection of an RP2D, part B, a dose expansion portion, will be initiated with the primary objective of clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab in patients with select advanced solid tumors. Part C will evaluate safety and tolerability of RP2D in patients with renal insufficiency. ;
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