CT-95 in Advanced Cancers Associated With Mesothelin Expression

Conditions: 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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1

Enrollment: 70

Sponsor: Context Therapeutics Inc.

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 Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06756035). StuddyBuddy aggregates publicly available trial information.