Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 8, 2026
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Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07545122). This is a study registration, not published results. Lead sponsor: Context Therapeutics Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 162 participants (ESTIMATED). Conditions: Triple Negative Breast Cancer (TNBC), Colorectal Cancer, Urothelial Cancer. Interventions: DRUG: CT-202. Primary outcome measures: Phase 1a: Incidence of Dose Limiting Toxicities (DLTs) , From date of first dose of CT-202 until 28 days following the first dose; Phase 1b: Overall response rate (ORR) , From date of first dose of CT-202until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. Brief 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.