|

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

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
Cancer Clinical Trials773-702-6233Cancerclinicaltrials@bsd.uchicago.edu
Context Investigational Site
Grand Rapids, Michigan, 49546
Ashley Spagnuolo616-954-5552ashley.spagnuolo@startresearch.com
Context Investigational Site
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office551-996-1777OncologyResearchReferral@hmhn.org
Context Investigational Site
Philadelphia, Pennsylvania, 19107
Ask Phase1215-586-0199AskPhase1@jefferson.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.