CT-95 in Advanced Cancers Associated With Mesothelin Expression
Recruiting now · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT06756035
- Run by
- Context Therapeutics Inc.
- People needed
- 70
- Starts
- 2025-03-31
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Context Investigational Site — Denver, Colorado, United States (enrolling)
- Context Investigational Site — Chicago, Illinois, United States (enrolling)
- Context Investigational Site — Grand Rapids, Michigan, United States (enrolling)
- Context Investigational Site — Hackensack, New Jersey, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Context Investigational Site — Philadelphia, Pennsylvania, United States (enrolling)
- Context Investigational Site — Nashville, Tennessee, United States (enrolling)
- Context Investigational Site — San Antonio, Texas, United States (enrolling)
- Context Investigational Site — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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