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RECRUITING
NCT07545122
PHASE1

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

Sponsor: Context Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2026-09

Completion Date

2030-01

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

CT-202

Nectin-4 bispecific

Locations (4)

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Tasman Oncology Research

Gold Coast, Queensland, Australia

Calvary Mater Hospital Newcastle

Newcastle, Queensland, Australia

Linear Clinical Research

Perth, Western Australia, Australia