Evaluating CTIM-76 for patients with recurring ovarian and other advanced cancers
Official title: A Phase 1, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Run by Context Therapeutics Inc. · NCT06515613 · Data updated 2026-11-12
This study is testing a new treatment called CTIM-76 to see if it can help people with hard-to-treat ovarian and other advanced cancers feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 156 (estimated) |
| Sponsor | Context Therapeutics Inc. Industry-sponsored |
| Locations | 16 sites (Little Rock, Arkansas and 15 other locations) |
| Status | Recruiting |
| Started | July 10, 2024 |
| Main results expected | May 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06515613 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with CLDN6 positive platinum-resistant ovarian cancer, advanced testicular cancer, or advanced endometrial cancer.
✕Probably not a fit
Patients with central nervous system metastases or those who have previously received CLDN-6 targeted therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study aims to assess the safety and efficacy of CTIM-76, a bispecific antibody targeting CLDN6, in patients with platinum-resistant ovarian cancer and other advanced solid tumors such as testicular and endometrial cancers. The trial consists of a dose escalation phase to determine the recommended dose for expansion and a subsequent dose expansion phase to evaluate the drug's effectiveness at selected doses. Participants will receive CTIM-76 weekly for 28-day cycles until disease progression or unacceptable toxicity occurs. The study will also analyze dose-response relationships based on safety and efficacy data.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment choices due to platinum resistance.
How similar studies have gone: While this approach is novel in targeting CLDN6 with a bispecific antibody, similar studies targeting other solid tumors have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States Recruiting -
SCRI at Denver Health
Denver, Colorado, United States Recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
University of Nebraska Medical
Omaha, Nebraska, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting -
Duke Cancer Institute
Durham, North Carolina, United States Recruiting
Show 10 more locations
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Providence Cancer Institute of Oregon
Portland, Oregon, United States Recruiting -
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States Recruiting -
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States Recruiting -
SCRI at Mary Crowley
Dallas, Texas, United States Recruiting -
University College London Hospital
London, United Kingdom Recruiting -
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States Withdrawn -
John Theurer Cancer Center
Hackensack, New Jersey, United States Terminated -
Gabrail Cancer Center
Canton, Ohio, United States Withdrawn -
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States Withdrawn -
The Royal Marsden NHS Foundation Trust
London, United Kingdom Active not recruiting
Study contacts
- Study coordinator: Context Clinical Development
- Email: cntx-ctim76-101@contexttherapeutics.com
- Phone: 267-225-7416
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.