About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
History of severe skin toxicity
Uncontrolled significant active infection or any medical or other condition that in the opinion of the Investigator would preclude the participant's participation in the study.
Concurrent participation in another investigational clinical trial.
Trial design
Treatments tested in this trial
- CT-202