RecruitingPhase 1NCT06756035

CT-95 in Advanced Cancers Associated With Mesothelin Expression

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

Sponsor

Context Therapeutics Inc.

Enrollment

70 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Mesothelin-Expressing Tumors Epithelial Ovarian Cancer Lung Adenocarcinoma Metastatic Malignant Pleural Mesothelioma, Advanced Malignant Peritoneal Mesothelioma, Advanced Pancreatic Adenocarcinoma Advanced or Metastatic Cholangiocarcinoma Advanced Cholangiocarcinoma Non-resectable Mesothelin-expressing Advanced Cancers Mesothelin-positive Advanced Malignant Solid Tumors

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests CT-95, a new investigational cancer drug that targets mesothelin — a protein found on the surface of several cancer types — in people with advanced cancers that express this protein (such as mesothelioma, ovarian cancer, or pancreatic cancer). **You may be eligible if...** - You are in good health (ECOG 0–1) - You have confirmed advanced cancer that expresses the mesothelin protein - You have evaluable or measurable disease on imaging - Your organ function is adequate **You may NOT be eligible if...** - You have an uncontrolled serious infection or medical condition that would prevent safe participation - You have previously received a mesothelin-targeted CAR-T therapy or CD3-targeted treatment - You are currently enrolled in another clinical trial - You have cancer spreading along the lining of the brain or spinal cord (leptomeningeal disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCT-95

MSLN bispecific antibody to be administered according to the dose and schedule of the assigned cohort until documentation of disease progression (or confirmed disease progression), unacceptable toxicity, or participant/physician decision.