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.”
Verismo doses first patient in advanced cancers therapy trial was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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by: sayeeda
published on GlobalData