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CT-95 in Advanced Cancers Associated With Mesothelin Expression

RecruitingPhase 1

Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.

What is being tested

Sponsor: Context Therapeutics Inc. · Participants: 70 · Started: Mar 31, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06756035

Locations in the U.S.

ColoradoContext Investigational Site, Denver
IllinoisContext Investigational Site, Chicago
MichiganContext Investigational Site, Grand Rapids
New JerseyContext Investigational Site, Hackensack
PennsylvaniaContext Investigational Site, Philadelphia
University of Pennsylvania, Philadelphia
TennesseeContext Investigational Site, Nashville
TexasContext Investigational Site, San Antonio
Context Investigational Site, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.