CT-95 for Advanced Cancers with Mesothelin Expression

This study is testing a new drug called CT-95 in people with advanced cancers that have a specific marker called mesothelin. These cancers include certain types of ovarian cancer, mesothelioma, and pancreatic cancer. CT-95 is a bispecific antibody, which is a type of medicine designed to target specific cells. The main goals are to find a safe dose of CT-95 and to see how often side effects occur. You might be able to join if you are 18 or older, have good general health, and your cancer has mesothelin. The study is currently unclear about its recruitment status and plans to enroll about 70 people.

Study design
This is a Phase 1a/1b, first-in-human, open-label study. It is designed to test different doses of CT-95 in approximately 70 participants.
What's involved
Participants will receive CT-95 intravenously once a week over a 4-week cycle. Treatment continues until the disease gets worse, side effects are too severe, or you or your doctor decide to stop.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for approximately 6 months after the first dose or until treatment stops, whichever comes first.

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NCT06756035

CT-95 in Advanced Cancers Associated With Mesothelin Expression

Recruiting
PHASE1Ages 18+InterventionalTreatment
Context Therapeutics Inc.
~70 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:CT-95

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the MTD or RD of CT-95 [Safety and Tolerability]
Measured over From date of first dose of CT-95 until 28 days following the first dose.
+1 more outcome measured
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
9 sites across 7 states
Pennsylvania2
Texas2
Colorado1
Illinois1
Michigan1
New Jersey1
Tennessee1
  • Karen Chagin, MD · STUDY_DIRECTOR · Context Therapeutics Inc.

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Eligibility criteria

Inclusion

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

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
  • Determine the MTD or RD of CT-95 [Safety and Tolerability]From date of first dose of CT-95 until 28 days following the first dose.

    The frequency of dose-limiting toxicities (DLTs) will be analyzed along with safety and tolerability measures to determine the MTD or RD of CT-95.

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

    The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed.