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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

RecruitingPhase 1

Sponsor: Context Therapeutics Inc.

Conditions: Triple Negative Breast Cancer (TNBC), Colorectal Cancer, Urothelial Cancer

Interventions: CT-202

Countries: Australia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (3)

Gold Coast, Queensland, Australia
Newcastle, Queensland, Australia
Perth, Western Australia, Australia