CT-95 for advanced cancers with mesothelin expression
Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
PHASE1 · Context Therapeutics Inc. · NCT06756035
This study is testing a new treatment called CT-95 to see if it can help people with advanced cancers that have a specific protein called mesothelin.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Context Therapeutics Inc. (industry) |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 8 sites (Denver, Colorado and 7 other locations) |
| Trial ID | NCT06756035 on ClinicalTrials.gov |
What this trial studies
This Phase 1a/1b open-label trial evaluates the safety and efficacy of CT-95, a humanized T cell engaging bispecific antibody targeting mesothelin, in patients with advanced solid tumors that express mesothelin. The study consists of a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further assess the drug's effectiveness in specific cancer types. Participants will receive CT-95 intravenously once a week over a four-week cycle. The trial aims to provide insights into the drug's safety profile and potential therapeutic benefits for patients with advanced cancers.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced mesothelin-expressing tumors who have an ECOG performance status of 0 or 1.
Not a fit: Patients with uncontrolled infections, prior treatment with specific targeted therapies, or concurrent participation in other trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced cancers associated with mesothelin expression.
How similar studies have performed: While this approach is novel in targeting mesothelin with a bispecific antibody, similar studies targeting other tumor markers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado and 7 other locations
- Context Investigational Site — Denver, Colorado, United States (RECRUITING)
- Context Investigational Site — Chicago, Illinois, United States (RECRUITING)
- Context Investigational Site — Grand Rapids, Michigan, United States (RECRUITING)
- Context Investigational Site — Hackensack, New Jersey, United States (RECRUITING)
- Context Investigational Site — Philadelphia, Pennsylvania, United States (RECRUITING)
- Context Investigational Site — Nashville, Tennessee, United States (RECRUITING)
- Context Investigational Site — San Antonio, Texas, United States (RECRUITING)
- Context Investigational Site — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Curtis Reinard
- Email: clinical@contexttherapeutics.com
- Phone: 267-225-7416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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