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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
Sponsor: Context Therapeutics Inc.
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
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