RECRUITING

CT-95 in Advanced Cancers Associated With Mesothelin Expression

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Conditions

Mesothelin-Expressing TumorsEpithelial Ovarian CancerMalignant Pleural Mesothelioma, AdvancedMalignant Peritoneal Mesothelioma, AdvancedPancreatic Adenocarcinoma Advanced or MetastaticLung Adenocarcinoma MetastaticCholangiocarcinoma AdvancedCholangiocarcinoma Non-resectableMesothelin-expressing Advanced CancersMesothelin-positive Advanced Malignant Solid TumorsColorectal CancerPhase 1 Dose Escalation StudyCT-95Advanced, recurrent cancersUnresectable, metastatic cancersCancers associated with mesothelin expression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-31
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06756035

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ECOG 0 or 1
  2. * Subjects with evaluable disease per RECIST 1.1 or mRECIST
  3. * Subjects with adequate organ function.
  4. * Subjects with advanced cancers associated with mesothelin expression
  1. * 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.
  2. * Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy
  3. * Concurrent participation in another investigational clinical trial.
  4. * Evidence of leptomeningeal disease

Contacts and Locations

Study Contact

Curtis Reinard
CONTACT
267-225-7416
clinical@contexttherapeutics.com

Principal Investigator

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

Study Locations (Sites)

Context Investigational Site
Hackensack, New Jersey, 07601
United States
Context Investigational Site
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Context Therapeutics Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Phase 1 Dose Escalation Study
  • CT-95
  • Advanced, recurrent cancers
  • Unresectable, metastatic cancers
  • Cancers associated with mesothelin expression

Additional Relevant MeSH Terms

  • 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