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

NCT07545122 | Not Yet Recruiting Phase 1

• 1 other identifier: CNTX-CT202-101
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Phase 1a

EXPERIMENTAL

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

Drug: CT-202

Phase 1b

EXPERIMENTAL

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

Drug: CT-202

Interventions

CT-202 DRUG

Nectin-4 bispecific

Phase 1a; Phase 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Context Therapeutics Inc.: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Context Clinical Development

CONTACT

267.225.7416; Cntx-ct202-101@contexttherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04