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CT-95 in Advanced Cancers Associated With Mesothelin Expression

NCT06756035 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-12

No results posted yet for this study

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.

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
  • Mesothelin-expressing Advanced Cancers
  • Mesothelin-positive Advanced Malignant Solid Tumors
  • Colorectal Cancer

Interventions

DRUG

CT-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.

Sponsors & Collaborators

  • Context Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Karen Chagin, MD · Context Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06756035 on ClinicalTrials.gov