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 (CT-202)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Urothelial Cancer; Triple Negative Breast Cancer (TNBC)
• Intervention / Treatment: Drug: CT-202

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Context Clinical Development; Phone Number: 267.225.7416; Email: Cntx-ct202-101@contexttherapeutics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a; Dose Escalation-Bayesian Optimal Interval (BOIN) Design with approximately 54 patients in dose escalation.	Drug: CT-202; Nectin-4 bispecific
Experimental: Phase 1b; Phase 1b: Dose Expansion - participants will be evaluated in 4-6 cohorts at different doses and schedules of CT-202	Drug: CT-202; Nectin-4 bispecific

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Incidence of Dose Limiting Toxicities (DLTs)	Phase 1a will evaluate increasing doses of CT-202 based on the assessment of DLTs	From date of first dose of CT-202 until 28 days following the first dose
Phase 1b: Overall response rate (ORR)	ORR will be based on the overall response rate as assessed by Investigators according to RECIST v1.1	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

Collaborators and Investigators

• Sponsor: Context Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: CNTX-CT202-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No