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CT-95 in Advanced Cancers Associated With Mesothelin Expression
RECRUITINGPhase 1Sponsored by Context Therapeutics Inc.
Actively Recruiting
PhasePhase 1
SponsorContext Therapeutics Inc.
Started2025-03-31
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →
NCT06756035
Summary
This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * ECOG 0 or 1 * Subjects with evaluable disease per RECIST 1.1 or mRECIST * Subjects with adequate organ function. * Subjects with advanced cancers associated with mesothelin expression Exclusion Criteria: * Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study. * Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy * Concurrent participation in another investigational clinical trial. * Evidence of leptomeningeal disease
Conditions13
CancerCholangiocarcinoma AdvancedCholangiocarcinoma Non-resectableColorectal CancerEpithelial Ovarian CancerLung Adenocarcinoma MetastaticLung CancerMalignant Peritoneal Mesothelioma, AdvancedMalignant Pleural Mesothelioma, AdvancedMesothelin-Expressing Tumors
Locations8 sites
Context Investigational Site
Denver, Colorado, 80218
Context Investigational Site
Chicago, Illinois, 60637
Context Investigational Site
Grand Rapids, Michigan, 49546
Context Investigational Site
Hackensack, New Jersey, 07601
Context Investigational Site
Philadelphia, Pennsylvania, 19107
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Actively Recruiting
PhasePhase 1
SponsorContext Therapeutics Inc.
Started2025-03-31
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →
NCT06756035