Verismo Therapeutics has dosed the first patient in the first-in-human Phase I STAR-101 clinical trial of SynKIR-110 to treat advanced cancers.
The dose-escalation, open-label, multicentre study is designed to assess the feasibility, safety, and potential activity of SynKIR-110 in patients with mesothelin-expressing solid tumours including advanced ovarian cancer, pleural mesothelioma, and cholangiocarcinoma.
Up to 42 participants aged 18 years and above will receive a single intravenous dose of SynKIR-110. They will be divided into up to six cohorts of three to six subjects in each cohort.
Doses will be escalated in a standard 3+3 pattern until a maximum tolerated dose (MTD), or a maximum feasible dose (MFD) is reached.
To further assess the safety and potential activity of SynKIR-110, an additional six to nine subjects will be enrolled at the MTD/MFD.
The study also includes an intervention period where subjects will receive non-myeloablative lymphodepleting chemotherapy followed by a single infusion of SynKIR-110.
Subjects will be followed for 12 months or until disease progression.
The SynKIR-110 product comprises autologous T cells transduced with a mesothelin-targeted KIR-CAR platform.
This platform is a dual-chain CAR T cell therapy that is capable of maintaining antitumour T cell activity in challenging solid tumour environments.
Last June, Verismo and the University of Pennsylvania (Penn) entered a sponsored research agreement to expedite new treatment options for solid tumour indications.
Verismo Therapeutics co-founder and CEO Dr Bryan Kim said: “This represents a significant milestone for our company and demonstrates the commitment of our team to address the critical need for additional treatment options for patients with mesothelin-expressing solid tumours.
“We're proud to work with the distinguished team at Penn to take our SynKIR-110 treatment out of the lab and to the patients with unmet medical needs.”
