CT-95 in Advanced Cancers Associated With Mesothelin Expression

Last updated: July 29, 2025
Sponsor: Context Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lung Cancer

Cancer

Colon Cancer; Rectal Cancer

Treatment

CT-95

Clinical Study ID

NCT06756035
CNTX-CT95-101
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ECOG 0 or 1

  • Subjects with evaluable disease per RECIST 1.1 or mRECIST

  • Subjects with adequate organ function.

  • Subjects with advanced cancers associated with mesothelin expression

Exclusion

Exclusion Criteria:

  • Uncontrolled significant active infection or any medical or other condition that inopinion of the investigator would preclude the subject's participation in the study.

  • Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T)therapy

  • Concurrent participation in another investigational clinical trial.

  • Evidence of leptomeningeal disease

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: CT-95
Phase: 1
Study Start date:
March 31, 2025
Estimated Completion Date:
December 31, 2028

Study Description

The Phase 1a Dose Escalation portion of the trial will enroll subjects in one of approximately 8 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE[s]) for further study in 2 dose optimization cohorts. Subjects will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.

The Phase 1b Dose Expansion portion will evaluate CT-95 in indication-specific expansion cohorts

Connect with a study center

  • Context Investigational Site

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Context Investigational Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Context Investigational Site

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Context Investigational Site

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Context Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Context Investigational Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Context Investigational Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.