RecruitingPhase 1NCT06756035

CT-95 in Advanced Cancers Associated With Mesothelin Expression

Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression

Sponsor

Context Therapeutics Inc.

Enrollment

70 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Mesothelin-Expressing Tumors Epithelial Ovarian Cancer Lung Adenocarcinoma Metastatic Malignant Pleural Mesothelioma, Advanced Malignant Peritoneal Mesothelioma, Advanced Pancreatic Adenocarcinoma Advanced or Metastatic Cholangiocarcinoma Advanced Cholangiocarcinoma Non-resectable Mesothelin-expressing Advanced Cancers Mesothelin-positive Advanced Malignant Solid Tumors

Summary

This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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