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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorContext Therapeutics Inc.

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

Treatment groups

162 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators