Recruiting

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

Phase 1a Dose Escalation: Participants with ovarian epithelial tumors, primary peritoneal or fallopian tube cancer (PROC), epithelioid mesothelioma, lung adenocarcinoma, pancreatic adenocarcinoma, colorectal cancer, cholangiocarcinoma, and gastric/GEJ adenocarcinomas will be enrolled in one of approximately 9 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 dose expansion cohorts. Participants will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle. Phase 1b Dose Expansion: The RDE(s) of CT-95 determined in Phase 1a will be evaluated in 2-4 indication-specific expansion cohorts of up to 20 subjects each (i.e. up to 80 participants total). Different indications, dose levels, and/or schedules may be explored. The expansion doses and/or dosing schedules for Phase 1b will be determined by Sponsor in conjunction with SRC based upon all available safety, PK, PD, biomarker, and preliminary efficacy data from Phase 1a.

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: 2026-06-12

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