Status:
RECRUITING
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Lead Sponsor:
Context Therapeutics Inc.
Conditions:
Platinum-resistant Ovarian Cancer
Testicular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 participant...
Detailed Description
The phase 1a Dose Escalation portion of the trial will enroll participants with PRROC, testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerabil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06515613
Start Date
July 10 2024
End Date
April 30 2028
Last Update
January 7 2026
Active Locations (11)
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1
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
2
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States, 90212
3
SCRI at Denver Health
Denver, Colorado, United States, 80218
4
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601