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

Recruiting now · Phase 1

Conditions studied: Platinum-resistant Ovarian Cancer, Testicular Cancer, Endometrial Cancer

In brief

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).

Key facts

Study ID

NCT06515613

Run by

Context Therapeutics Inc.

People needed

156

Starts

2024-07-10

Expected to finish

2028-12-31

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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