RecruitingPhase 1NCT07545122

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

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


Sponsor

Context Therapeutics Inc.

Enrollment

162 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CT-202 for people with colorectal, cancer, triple negative breast cancer(tnbc), and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCT-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

View Full Details on ClinicalTrials.gov

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NCT07545122


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