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A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
RECRUITINGPhase 1Sponsored by Context Therapeutics Inc.
Actively Recruiting
PhasePhase 1
SponsorContext Therapeutics Inc.
Started2024-07-10
Est. completion2027-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →
NCT06515613
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 participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions4
CancerEndometrial CancerPlatinum-resistant Ovarian CancerTesticular Cancer
Interventions1
Locations13 sites
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
Precision NextGen Oncology & Research Center
SCRI at Denver Health
Dana-Farber Cancer Institute
John Theurer Cancer Center
Hackensack, New Jersey, 07601
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Actively Recruiting
PhasePhase 1
SponsorContext Therapeutics Inc.
Started2024-07-10
Est. completion2027-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →
NCT06515613