Overview
This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.
Description
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
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
