NCT06756035

CT-95 in Advanced Cancers Associated With Mesothelin Expression

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Context Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.

Detailed description

The Phase 1a Dose Escalation portion of the trial will enroll subjects in one of approximately 8 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE\[s\]) for further study in 2 dose optimization cohorts. Subjects will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle. The Phase 1b Dose Expansion portion will evaluate CT-95 in indication-specific expansion cohorts

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

Type	Name	Description
DRUG	CT-95	Weekly IV dosing

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2025-01-01
• Last updated: 2025-07-31

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study