Recruiting
Phase 1

CT-95

Sponsor:

Context Therapeutics Inc.

Code:

NCT06756035

Conditions

Mesothelin-Expressing Tumors

Epithelial Ovarian Cancer

Malignant Pleural Mesothelioma, Advanced

Malignant Peritoneal Mesothelioma, Advanced

Pancreatic Adenocarcinoma Advanced or Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CT-95

Study Details

Brief 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

Study ID

NCT06756035

Start date

Mar 31, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CT-95

Phase 1a: Dose Escalation - each dose cohort will assess toxicity 28 days following the first dose of CT95 anticipate a total of 8 dose cohorts.

Phase 1b: Dose Expansion - approximately 80 participants will be evaluated in 2-4 indication-specific expansion cohorts.

Interventions

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.

Primary outcome measure

  • Determine the MTD or RD of CT-95 [Safety and Tolerability] [ Time Frame: From date of first dose of CT-95 until 28 days following the first dose. ]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first. ]

Central Contacts and Locations

Central contacts

Context Clinical Development

267-225-7416cntx-ct95-101@contexttherapeutics.com

Locations

Context Investigational Site

Recruiting

Denver, Colorado, United States, 80218

Contacts

Front Desk

720-754-2610CANN.DDUDenverGeneral@SarahCannon.com

Context Investigational Site

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Cancer Clinical Trials

773-702-6233Cancerclinicaltrials@bsd.uchicago.edu

Context Investigational Site

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Ashley Spagnuolo

616-954-5552ashley.spagnuolo@startresearch.com

Context Investigational Site

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777OncologyResearchReferral@hmhn.org

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Andrea Standish

215-662-2419Andrea.Standish@Pennmedicine.upenn.edu

Context Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Ask Phase1

215-586-0199AskPhase1@jefferson.edu

Context Investigational Site

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Sarah Cannon Research Institute

844-482-4812

Context Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Clinical Trial Navigator

210-580-9521jgeorg@nextoncology.com

Context Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Isabel Jimenez

210-593-5265isabel.jimenez@startresearch.com

Christina Santana

csantana@startresearch.com

More Information

Sponsor

Context Therapeutics Inc.

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Context Therapeutics Inc. on 2026-06-12.