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RecruitingPhase 1

CT-95 in Advanced Cancers Associated With Mesothelin Expression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CT-95 alone in people with advanced cancers linked to a protein called mesothelin. These cancers have come back, cannot be removed by surgery, or have spread. This is the first study of CT-95 in humans, testing its safety, how it works in the body, and its effects on cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are fully active or can do light activities despite some limits on harder physical activity.
  • Your cancer can be checked using the study's standard cancer assessment rules.
  • Your organs are working well enough for the study.
  • You have advanced cancer linked to the protein mesothelin.

Who can't join

  • You have a serious active infection that is not controlled, or another condition the study doctor thinks would prevent you from taking part.
  • You previously had CD3-based treatment or CAR-T cell therapy aimed at mesothelin. These treatments use immune cells to fight cancer.
  • You are taking part in another clinical trial of an experimental treatment at the same time.
  • There is evidence of cancer in the tissues and fluid around your brain and spinal cord.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (9)

CO

IL

MI

NJ

PA

TN

TX