CT-95 in Advanced Cancers Associated With Mesothelin Expression
Recruiting · NCT06756035 · Interventional (participants receive a specific treatment) · Lead sponsor: Context Therapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
CT-95
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
9 locations listed across 7 US states.
- Context Investigational Site - Denver, Colorado, United States
- Context Investigational Site - Chicago, Illinois, United States
- Context Investigational Site - Grand Rapids, Michigan, United States
- Context Investigational Site - Hackensack, New Jersey, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Context Investigational Site - Philadelphia, Pennsylvania, United States
- Context Investigational Site - Nashville, Tennessee, United States
- Context Investigational Site - San Antonio, Texas, United States
- Context Investigational Site - San Antonio, Texas, United States