CT-95 in Advanced Cancers Associated With Mesothelin Expression

Description

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.

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

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Study Overview

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Study Details

Study overview

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.

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

CT-95 in Advanced Cancers Associated With Mesothelin Expression

Condition
Mesothelin-Expressing Tumors
Intervention / Treatment

-

Contacts and Locations

Hackensack

Context Investigational Site, Hackensack, New Jersey, United States, 07601

San Antonio

Context Investigational Site, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Context Therapeutics Inc.,

Karen Smith, MD, PhD, MBA, LLM, STUDY_DIRECTOR, Context Therapeutics Inc.

Study Record Dates

2028-12