CT-95 in Advanced Cancers Associated With Mesothelin Expression
Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
1 other identifier
interventional
70
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2024
CompletedFirst Posted
Study publicly available on registry
January 1, 2025
CompletedStudy Start
First participant enrolled
March 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
June 12, 2026
June 1, 2026
1.7 years
December 18, 2024
June 10, 2026
Conditions
Keywords
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.
- +1 more secondary outcomes
Study Arms (1)
CT-95
EXPERIMENTALPhase 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
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Context Investigational Site
Denver, Colorado, 80218, United States
Context Investigational Site
Chicago, Illinois, 60637, United States
Context Investigational Site
Grand Rapids, Michigan, 49546, United States
Context Investigational Site
Hackensack, New Jersey, 07601, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Context Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Context Investigational Site
Nashville, Tennessee, 37203, United States
Context Investigational Site
San Antonio, Texas, 78229, United States
Context Investigational Site
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karen Chagin, MD
Context Therapeutics Inc.
Central Study Contacts
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
June 12, 2026
Record last verified: 2026-06