Treatment for advanced cancers expressing mesothelin

A Phase 1 Study of SynKIR-110, Autologous T Cells Transduced With Mesothelin KIR-CAR, in Subjects With Mesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, or Mesothelioma

This study is testing a new treatment called SynKIR-110 to see if it is safe and works for people with advanced cancers that have a specific protein called mesothelin, like ovarian cancer and mesothelioma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Verismo Therapeutics (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Tampa, Florida and 4 other locations)
• Trial ID: NCT05568680 on ClinicalTrials.gov

What this trial studies

This Phase 1 trial evaluates the safety and feasibility of a single intravenous dose of SynKIR-110 in patients with advanced mesothelin-expressing tumors, including ovarian cancer, cholangiocarcinoma, and mesothelioma. The study involves a multicenter, open-label, dose-escalation design, where up to 42 subjects will receive treatment and be monitored for safety and potential activity. Participants will undergo a screening period, followed by a treatment phase with lymphodepleting chemotherapy and the investigational product, and will be followed for 12 months or until disease progression.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed recurrent advanced ovarian cancer, cholangiocarcinoma, or mesothelioma after at least one prior systemic therapy.

Not a fit: Patients with active invasive cancers other than the specified types or those with a history of T or B cell malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that currently have limited treatment options.

How similar studies have performed: While this approach is novel, similar studies targeting mesothelin-expressing tumors have shown promise, indicating potential for success.

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

Where this trial is running

Tampa, Florida and 4 other locations

• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
• University of Kansas Cancer Center — Westwood, Kansas, United States (Recruiting)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Physician Connect

Conditions Ovarian Cancer; Cholangiocarcinoma Recurrent; Mesothelioma, Malignant