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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06756035.
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.
Lead OrganizationContext Therapeutics Inc.
Principal InvestigatorKaren Chagin
