A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers

Overview

This is a Phase 1a/1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.

Phase 1a Dose Escalation: Will follow a Bayesian Optimal Interval (BOIN) design (Liu, 2015) with step up dosing (i.e. priming followed by full doses of CT-202), Q2W administration schedule, and approximately 6 dose levels. Participants will continue study treatment until confirmed disease progression, the occurrence of unacceptable toxicity, withdrawal from the study or decision to discontinue treatment by the investigator. Phase 1b Dose Expansion: Upon completion of the dose escalation Phase 1a, CT-202 may be evaluated at 2 or more dose levels and 2 or more dosing schedules in at least 4 but up to 6 expansion cohorts. The population(s) will include participants with the same tumor indications, or subsets, evaluated in the dose escalation phase (TNBC, CRC, or UC). Up to 15 participants will be assigned to each dosing cohort. Based on the totality of data from Phase 1b, a RP2D for future clinical studies will be determined.

Conditions