CT-95 in Advanced Cancers Associated With Mesothelin Expression

NCT06756035 · Context Therapeutics Inc.

Recruiting

In plain English

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Official title

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

About this study

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

Eligibility criteria

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 target: 70 participants

Allocation: na

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2025-03-31

Estimated completion: 2028-12

Last updated: 2025-07-31

Interventions

Drug: CT-95

Primary outcomes

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

Sponsor

Context Therapeutics Inc. · industry