CT-95 in Advanced Cancers Associated With Mesothelin Expression
About this 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.
- Condition
- Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced, Malignant Peritoneal Mesothelioma, Advanced, Pancreatic Adenocarcinoma Advanced or Metastatic, Lung Adenocarcinoma Metastatic, Cholangiocarcinoma Advanced, Cholangiocarcinoma Non-resectable, Mesothelin-expressing Advanced Cancers, Mesothelin-positive Advanced Malignant Solid Tumors, Colorectal Cancer
- Tested
- CT-95
- Sponsor
- Context Therapeutics Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced, Malignant Peritoneal Mesothelioma, Advanced, Pancreatic Adenocarcinoma Advanced or Metastatic, Lung Adenocarcinoma Metastatic, Cholangiocarcinoma Advanced, Cholangiocarcinoma Non-resectable, Mesothelin-expressing Advanced Cancers, Mesothelin-positive Advanced Malignant Solid Tumors, Colorectal Cancer
- 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 4
- 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
9 sites, 9 recruiting
Context Investigational Site
Chicago, Illinois, United States
Context Investigational Site
Denver, Colorado, United States
Context Investigational Site
Grand Rapids, Michigan, United States
Context Investigational Site
Hackensack, New Jersey, United States
Context Investigational Site
Nashville, Tennessee, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
and 3 more sites on ClinicalTrials.gov
Contact
-
Context Clinical Development
267-225-7416 cntx-ct95-101@contexttherapeutics.com
Potential match only. Final eligibility is determined by the study team.