Clinical trial Recruiting at 11 sites Phase 1 Interventional Ages 18 and up

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.

More Endometrial Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment156 (estimated)
SponsorContext Therapeutics Inc.
Industry-sponsored
Locations16 sites (Little Rock, Arkansas and 15 other locations)
StatusRecruiting
StartedJuly 10, 2024
Main results expectedMay 31, 2028
Study endsDecember 31, 2028
Registry record updatedNovember 10, 2026
Trial IDNCT06515613 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.