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RECRUITING Phase 1 ClinicalTrials.gov

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. • ClinicalTrials.gov ID: NCT07545122

Registry updated: 2026-10-08
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Description

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.

Interventions

  • CT-202 (Drug)
    Nectin-4 bispecific

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

Triple Negative Breast Cancer (TNBC) Colorectal Cancer Urothelial Cancer

Locations

  • Sydney Adventist Hospital — Wahroonga, New South Wales, Australia
  • Crown Princess Mary Cancer Centre Westmead Hospital — Westmead, New South Wales, Australia
  • Tasman Oncology Research — Gold Coast, Queensland, Australia
  • Calvary Mater Hospital Newcastle — Newcastle, Queensland, Australia
  • Olivia Newton John Cancer Centre — Heidelberg, Victoria, Australia
  • Linear Clinical Research — Perth, Western Australia, Australia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record