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Phase 1Recruiting

SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

Sponsored by Verismo Therapeutics

About this study

This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma.

This is a Phase 1, FIH, multicenter, open-label, dose-escalation pilot study of a single IV gravity drip infusion of SynKIR-110 in subjects with advanced, mesothelin-expressing tumors (ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or mesothelioma). Up to 42 subjects will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Informed consent will be obtained from subjects prior to participation in this study. The study includes an enrollment screening period (which includes pre-leukapheresis safety/eligibility and leukapheresis visits), treatment period (administration of non-myeloablative lymphodepleting chemotherapy followed by a single infusion of investigational product), and a 12-month follow-up period or until diseas…

Where this study is enrolling (4)

Who can participate

Inclusion criteria

  • ✓Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease
  • ✓Adult 18 years of age or older.
  • ✓Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • ✓Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma.
  • ✓Satisfactory Blood coagulation parameters
  • ✓Satisfactory organ and bone marrow function

Exclusion criteria

  • ✕Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years.
  • ✕History of T or B cell malignancies or previous gene-engineered T cell therapies.
  • ✕Sarcomatoid/biphasic mesothelioma.
  • ✕Pulmonary exclusions
  • ✕Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease
  • ✕Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
  • ✕Active autoimmune disease

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.