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Recruiting NCT05568680

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

Conditions: Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 42
Sponsor: Verismo Therapeutics

Location: Moffitt Cancer Center Tampa Florida

Summary

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05568680). StuddyBuddy aggregates publicly available trial information.