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RECRUITING Phase 1 ClinicalTrials.gov

A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors

Sponsor: Context Therapeutics Inc. • ClinicalTrials.gov ID: NCT06515613

Registry updated: 2026-09-03
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Description

This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).

Interventions

  • CTIM-76 (Drug)
    CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.

Eligibility criteria

Inclusion Criteria: * Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer. * Participants with measurable disease per RECIST 1.1. * ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks. * Participants with adequate organ function. Exclusion Criteria: * Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression. * Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study. * Concurrent participation in another investigational clinical trial.

Conditions

Platinum-resistant Ovarian Cancer Testicular Cancer Endometrial Cancer

Locations

  • University of Arkansas Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States
  • Precision NextGen Oncology & Research Center — Beverly Hills, California, United States
  • SCRI at Denver Health — Denver, Colorado, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • University of Nebraska Medical — Omaha, Nebraska, United States
  • John Theurer Cancer Center — Hackensack, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Duke Cancer Institute — Durham, North Carolina, United States
  • Gabrail Cancer Center — Canton, Ohio, United States
  • Providence Cancer Institute of Oregon — Portland, Oregon, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
  • Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
  • SCRI at Mary Crowley — Dallas, Texas, United States
  • University College London Hospital — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record