drugset / Trial / NCT07545122

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

NCT07545122 ↗

Phase 1 Not yet recruiting 162 enrolled Context Therapeutics Inc.
RandomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-09
Primary completion
2030-01
Completion
2030-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CT-202 Unknown — —