Ovarian Cancer Clinical Trial

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

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.

View Full Description

Full Description

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 initial tumor biomarker screening, followed by 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 disease progression. Subjects will be followed for 12 months or until disease progression, at which point they will be invited to participate in a long-term safety follow-up study.

Up to 6 cohorts of 3 to 6 subjects per cohort will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Doses will be escalated following a standard 3 + 3 design until either an MTD or MFD is reached. An additional 6 to 9 subjects will be enrolled at the MTD/MFD to further assess safety and potential activity of SynKIR-110.

View Eligibility Criteria

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.
For ovarian cancer and mesothelioma, tumor expression of mesothelin ≥50% of tumor cells with ≥2+ staining intensity (on a scale of 0 to 3). For cholangiocarcinoma ≥10% of cells at any staining intensity (≥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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT05568680

Recruitment Status:

Recruiting

Sponsor:

Verismo Therapeutics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Katie Elkins
Contact
215-615-6740
[email protected]
Janos Tanyi, MD, PhD
Principal Investigator
MDAnderson
Houston Texas, 77030, United States More Info
Rachelle David, BSN,RN
Contact
281-684-5271
[email protected]
Mehmet Altan, MD
Principal Investigator
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT05568680

Recruitment Status:

Recruiting

Sponsor:


Verismo Therapeutics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.