Evaluating CTIM-76 for patients with recurring ovarian and other advanced cancers
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
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Context Therapeutics Inc. Industry-sponsored |
| Locations | 13 sites (Little Rock, Arkansas and 12 other locations) |
| Trial ID | NCT06515613 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with CLDN6 positive platinum-resistant ovarian cancer, advanced testicular cancer, or advanced endometrial cancer.
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.
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 performed: While this approach is novel in targeting CLDN6 with a bispecific antibody, similar studies targeting other solid tumors have shown promising results.
Eligibility criteria
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 this trial is running
Little Rock, Arkansas and 12 other locations
- University of Arkansas Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States (Recruiting)
- Precision NextGen Oncology & Research Center — Beverly Hills, California, United States (Withdrawn)
- SCRI at Denver Health — Denver, Colorado, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- John Theurer Cancer Center — Hackensack, New Jersey, United States (Terminated)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Duke Cancer Institute — Durham, North Carolina, United States (Recruiting)
- Gabrail Cancer Center — Canton, Ohio, United States (Withdrawn)
- Providence Cancer Institute of Oregon — Portland, Oregon, United States (Recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Withdrawn)
- 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)
Study contacts
- Study coordinator: MaryBeth LeRose
- Email: clinical@contexttherapeutics.com
- Phone: 267-225-7416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.