CT-95 in Advanced Cancers Associated With Mesothelin Expression

NCT06756035 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CNTX-CT95-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

Brief 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.

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

Keywords

Phase 1 Dose Escalation Study; CT-95; Advanced, recurrent cancers; Unresectable, metastatic cancers; Cancers associated with mesothelin expression

Outcome Measures

Primary Outcomes (2)

• Determine the MTD or RD of CT-95 [Safety and Tolerability]

  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.

  From date of first dose of CT-95 until 28 days following the first dose.

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

  From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

Secondary Outcomes (6)

• Evaluate Response Rates [Anti-tumor Activity]

  At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first

• Evaluate Progression-free Survival [Anti-tumor Activity]

  At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

• Evaluate Overall Survival [Survival]

  From the time of the first dose of CT-95 until approximately two years post-first dose.

• Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics]

  From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.

• Evaluate the Area Under the Curve (AUC) [Pharmacokinetics]

  From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.

Study Arms (1)

CT-95

EXPERIMENTAL

Each dose cohort will have weekly dosing. Anticipate approximately 8 dose cohorts.

Drug: CT-95

Interventions

CT-95 DRUG

Weekly IV dosing

CT-95

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Context Therapeutics Inc.: lead

Study Sites (8)

Context Investigational Site

Denver, Colorado, 80218, United States

RECRUITING

Context Investigational Site

Chicago, Illinois, 60637, United States

RECRUITING

Context Investigational Site

Grand Rapids, Michigan, 49546, United States

RECRUITING

Context Investigational Site

Hackensack, New Jersey, 07601, United States

RECRUITING

Context Investigational Site

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Context Investigational Site

Nashville, Tennessee, 37203, United States

RECRUITING

Context Investigational Site

San Antonio, Texas, 78229, United States

RECRUITING

Context Investigational Site

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Mesothelioma, Malignant; Neoplasm Metastasis; Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Karen Chagin, MD

  Context Therapeutics Inc.

  STUDY DIRECTOR

Central Study Contacts

Curtis Reinard

CONTACT

267-225-7416; clinical@contexttherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 1, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (8)