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

Phase 1

Recruiting

• Conditions: Ovarian Cancer; Cholangiocarcinoma Recurrent; Mesothelioma, Malignant

• Registration Number: NCT05568680
• Lead Sponsor: Verismo Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-9-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Inclusion Criteria:<br><br> - Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary<br> peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial<br> mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy<br> for advanced disease<br><br> - Adult 18 years of age or older.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.<br><br> - Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma<br> or lesions measurable for mRECIST for mesothelioma.<br><br> - Satisfactory Blood coagulation parameters<br><br> - Satisfactory organ and bone marrow function<br><br>Exclusion Criteria:<br><br> - Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian<br> unless surgically and medically cured without evidence of recurrent disease for 5<br> years.<br><br> - History of T or B cell malignancies or previous gene-engineered T cell therapies.<br><br> - Sarcomatoid/biphasic mesothelioma.<br><br> - Pulmonary exclusions<br><br> - Have acquired hereditary, congenital immunodeficiency or have recognized<br> immunodeficiency disease<br><br> - Active hepatitis B, active hepatitis C, or any HIV infection at the time of<br> screening<br><br> - Active autoimmune disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and Feasibility of SynKIR-110

Secondary Outcome Measures

Name	Time	Method
Define the maximum tolerated dose (MTD)/maximum feasible dose (MFD) of SynKIR-110 and to identify a recommended Phase 2 dose