Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Colorado
Context Investigational Site
RECRUITING
Denver
Illinois
Context Investigational Site
RECRUITING
Chicago
Michigan
Context Investigational Site
RECRUITING
Grand Rapids
New Jersey
Context Investigational Site
RECRUITING
Hackensack
Pennsylvania
Context Investigational Site
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Context Investigational Site
RECRUITING
Nashville
Texas
Context Investigational Site
RECRUITING
San Antonio
Context Investigational Site
RECRUITING
San Antonio
Contact Information
Primary
Context Clinical Development
cntx-ct95-101@contexttherapeutics.com
267-225-7416
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2028-12
Participants
Target number of participants: 70
Treatments
Experimental: CT-95
Phase 1a: Dose Escalation - each dose cohort will assess toxicity 28 days following the first dose of CT95 anticipate a total of 8 dose cohorts.~Phase 1b: Dose Expansion - approximately 80 participants will be evaluated in 2-4 indication-specific expansion cohorts.
Related Therapeutic Areas
Sponsors
Leads: Context Therapeutics Inc.