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Search / Trial NCT06756035

CT-95 in Advanced Cancers Associated With Mesothelin Expression

Launched by CONTEXT THERAPEUTICS INC. · Dec 24, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Phase 1 Dose Escalation Study Ct 95 Advanced, Recurrent Cancers Unresectable, Metastatic Cancers Cancers Associated With Mesothelin Expression

ClinConnect Summary

This clinical trial is studying a new treatment called CT-95 for patients with advanced cancers that express a protein called mesothelin. Mesothelin is found in certain types of tumors, including advanced ovarian cancer, lung cancer, and pancreatic cancer, among others. This trial aims to see how safe and effective CT-95 is for treating these cancers. It is currently open for patients aged 65 and older who have specific types of advanced solid tumors that can be measured by doctors.

To participate, patients should have good overall health, meaning they can carry out daily activities with little to no assistance. However, those with serious infections or who have received certain prior treatments for their cancer might not be eligible. Participants in the trial will receive CT-95 and will be closely monitored for any side effects and how well the treatment works. This study is important as it could provide new options for patients with challenging cancers that have limited treatment choices.

Gender

ALL

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

About Context Therapeutics Inc.

Context Therapeutics Inc. is a biopharmaceutical company focused on advancing innovative therapeutics for women’s health, particularly in the treatment of hormone-driven cancers. The company leverages a robust pipeline of drug candidates designed to target specific biological pathways, aiming to address unmet medical needs while improving patient outcomes. With a commitment to scientific excellence and patient-centric approaches, Context Therapeutics is dedicated to transforming the landscape of oncology through rigorous clinical development and collaboration with leading researchers and institutions.

Locations

San Antonio, Texas, United States

Hackensack, New Jersey, United States

Patients applied

0 patients applied

Trial Officials

Karen Smith, MD, PhD, MBA, LLM

Study Director

Context Therapeutics Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported