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.
Study ID
NCT07545122
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CT-202 — DRUG
    Nectin-4 bispecific

Study Details

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 Dates

First listed
Apr 22, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a
    Dose Escalation-Bayesian Optimal Interval (BOIN) Design with approximately 54 patients in dose escalation.
  • Experimental: Phase 1b
    Phase 1b: Dose Expansion - participants will be evaluated in 4-6 cohorts at different doses and schedules of CT-202

Primary Outcome Measure

Phase 1a: Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: From date of first dose of CT-202 until 28 days following the first dose ]

Central Contacts

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