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, and Urothelial Cancers
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.
• Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies
• Participants with measurable disease per RECIST 1.1
• ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks
• Participants have adequate organ function.