CT-95 in Advanced Cancers Associated With Mesothelin Expression
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(s) | Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced, Malignant Peritoneal Mesothelioma, Advanced, Pancreatic Adenocarcinoma Advanced or Metastatic, Lung A |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Context Therapeutics Inc. |
| Locations | Denver, Colorado, United States; Chicago, Illinois, United States; Grand Rapids, Michigan, United States; Hackensack, New Jersey, United States; Philadelphia, Pennsylvania, United States; Philadelphia, Pennsylvania, United States (+3 more sites) |
| Start date | 2025-03-31 |
| NCT ID | NCT06756035 |
| Official listing | https://clinicaltrials.gov/study/NCT06756035 |