RECRUITINGPhase 1INTERVENTIONAL
CT-95 in Advanced Cancers Associated With Mesothelin Expression
Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- ECOG 0 or 1
- Subjects with evaluable disease per RECIST 1.1 or mRECIST
- Subjects with your organs (liver, kidneys, etc.) are working well enough based on blood tests.
- Subjects with advanced cancers associated with mesothelin expression
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
CT-95
Weekly IV dosing
Locations (8)
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
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