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

Context Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Triple Negative Breast Cancer (TNBC); Urothelial Cancer; Colorectal Cancer

Treatments: Drug: CT-202

Study type: Interventional

Funder types: Industry

Identifiers

NCT07545122

CNTX-CT202-101

Details and patient eligibility

About

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.

Full description

Phase 1a Dose Escalation: Will follow a Bayesian Optimal Interval (BOIN) design (Liu, 2015) with step up dosing (i.e. priming followed by full doses of CT-202), Q2W administration schedule, and approximately 6 dose levels. Participants will continue study treatment until confirmed disease progression, the occurrence of unacceptable toxicity, withdrawal from the study or decision to discontinue treatment by the investigator.

Phase 1b Dose Expansion: Upon completion of the dose escalation Phase 1a, CT-202 may be evaluated at 2 or more dose levels and 2 or more dosing schedules in at least 4 but up to 6 expansion cohorts. The population(s) will include participants with the same tumor indications, or subsets, evaluated in the dose escalation phase (TNBC, CRC, or UC). Up to 15 participants will be assigned to each dosing cohort.

Based on the totality of data from Phase 1b, a RP2D for future clinical studies will be determined.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Phase 1a

Experimental group

Description:

Dose Escalation-Bayesian Optimal Interval (BOIN) Design with approximately 54 patients in dose escalation.

Treatment:

Drug: CT-202

Phase 1b

Experimental group

Description:

Phase 1b: Dose Expansion - participants will be evaluated in 4-6 cohorts at different doses and schedules of CT-202

Treatment:

Drug: CT-202