On February 22, 2023 Grid Therapeutics, LLC, a clinical stage biotechnology company developing human-derived antibodies, reported the initiation of a combination Phase 2 investigator-sponsored study of its lead asset, GT103 (Press release, Grid Therapeutics, FEB 22, 2023, View Source [SID1234627739]). In this clinical trial, Grid’s GT103, a novel, first-in-class antibody targeting complement factor H, will be administered in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. The trial will enroll patients with refractory non-small cell lung cancer ("NSCLC") who have progressed on no more than two lines of systemic therapy, including prior PD-1 treatment.
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"We are very excited to initiate this study to determine whether the therapy demonstrates clinical activity and tolerability observed in patients with advanced stage lung cancer in the Phase 1b study of GT103 alone"
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In this open-label, multi-center, single-arm Phase 2 clinical trial, Merck and Grid are each providing their respective drugs and funding support. This study is led by Jeff Clarke, M.D, member of the Duke Cancer Center Thoracic Clinic, Durham, NC. The study is managed by the Hoosier Cancer Research Network, a full-service contract research organization dedicated to providing efficiency and expertise in clinical trial services.
"We are very excited to initiate this study to determine whether the therapy demonstrates clinical activity and tolerability observed in patients with advanced stage lung cancer in the Phase 1b study of GT103 alone," said Dr. Clarke. "NSCLC is a difficult-to-treat cancer and patients, particularly in the relapsed/refractory setting, will benefit from novel therapeutic options to help improve disease outcomes."
About the Study
The Phase 2 open-label, clinical trial of GT103 is designed to assess the safety and tolerability of GT103 in combination with Merck’s pembrolizumab, as well as anti-tumor activity, response rates and overall survival. The study will enroll subjects with refractory NSCLC. Please refer to www.clinicaltrials.gov for additional clinical trial details.