Health Trials

CT-95 in Advanced Cancers Associated With Mesothelin Expression

ConditionsMesothelin-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 Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorContext Therapeutics Inc.

About this trial

This is a Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CT-95

Treatment groups

70 Participants
are divided into 1 treatment group

Locations

9
Colorado
Context Investigational Site80218, Denver United States
Illinois
Context Investigational Site60637, Chicago United States
Michigan
Context Investigational Site49546, Grand Rapids United States
New Jersey
Context Investigational Site07601, Hackensack United States

Sponsors and collaborators

Context Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov