CT-95 in Advanced Cancers Associated With Mesothelin Expression (NCT06756035) | Clinical Trial Compass
RecruitingPhase 1
CT-95 in Advanced Cancers Associated With Mesothelin Expression
United States70 participantsStarted 2025-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since CT-95 is in Phase 1 and the trial is specifically focused on finding the maximum tolerated dose, what does that mean for what's currently known about its safety profile, and how would that affect your recommendation for me personally?
2My cancer type is on the list of conditions this trial is studying — but how do you determine whether my tumor actually expresses mesothelin at a level that would make this trial worth considering?
3Because this is a dose-finding study, patients enrolled early may receive lower doses than what eventually proves most effective — how might the timing of when I join affect the potential benefit or risk I'd be exposed to?
4What kinds of treatment-emergent side effects are researchers watching for most closely with CT-95, and how do those risks compare to what I'd face with my current standard-of-care options?
5Given that this trial is still in Phase 1, would it make more sense for me to try established treatments first, or is there a reason you'd consider this trial a better path at this stage of my diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the MTD or RD of CT-95 [Safety and Tolerability]
Timeframe: From date of first dose of CT-95 until 28 days following the first dose.
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.