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RecruitingPhase 1NCT06756035
Official study title

CT-95 in Advanced Cancers Associated With Mesothelin Expression

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCT-95

The study team can explain what participation involves.

Who it may be forMesothelioma · Early-stage or resectable · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 12, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?Context Therapeutics Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Context Therapeutics Inc.
Interventions being studied
Drug: CT-95
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
Disease setting
Early-stage or resectable→Metastatic or stage IV→Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Context Investigational SiteDenver, Colorado
  • Context Investigational SiteChicago, Illinois
  • Context Investigational SiteGrand Rapids, Michigan
  • Context Investigational SiteHackensack, New Jersey
  • University of PennsylvaniaPhiladelphia, Pennsylvania
  • Context Investigational SitePhiladelphia, Pennsylvania
  • Context Investigational SiteNashville, Tennessee
  • Context Investigational SiteSan Antonio, Texas
  • Context Investigational SiteSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 12, 2026. Always confirm current availability with the study team.

View original record ↗