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NOT YET 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

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

CT-202

Nectin-4 bispecific

Locations (3)

Tasman Oncology Research

Gold Coast, Queensland, Australia

Calvary Mater Hospital Newcastle

Newcastle, Queensland, Australia

Linear Clinical Research

Perth, Western Australia, Australia