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

Starting soon · Phase 1

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

In brief

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.

Key facts

Study ID

NCT07545122

Run by

Context Therapeutics Inc.

People needed

162

Starts

2026-09-01

Expected to finish

2030-01-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tasman Oncology Research — Gold Coast, Queensland, Australia
• Calvary Mater Hospital Newcastle — Newcastle, Queensland, Australia
• Linear Clinical Research — Perth, Western Australia, Australia

Full record on ClinicalTrials.gov

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