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)

August 31, 2026 updated by: Context Therapeutics Inc.

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Wahroonga, New South Wales, Australia, 2076
        • Recruiting
        • Sydney Adventist Hospital
        • Contact:
    • Queensland
      • Gold Coast, Queensland, Australia
        • Recruiting
        • Tasman Oncology Research
      • Newcastle, Queensland, Australia
        • Recruiting
        • Calvary Mater Hospital Newcastle
    • Western Australia
      • Perth, Western Australia, Australia
        • Recruiting
        • Linear Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: From date of first dose of CT-202 until 28 days following the first dose
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)
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Context Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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