South Korea’s Qurient Gets FDA Approval to Conduct Solid Tumor Trial

February 10, 2022

South Korean biotech company Qurient has received FDA approval of its investigational new drug (IND) application for Q901, a small-molecule cancer drug candidate targeting cyclin dependent kinase 7 (CDK7) in solid tumors.

The company plans to enroll up to 70 patients with advanced solid tumors in a phase 1/2 U.S. trial, with the goal of determining the maximum tolerated dose, dose-limiting toxicities and the recommended phase 2 dose.

The study in patients with advanced solid tumors is expected to start in the second quarter of 2022, the company said. Q901 “may provide a new alternative treatment to patients with relapsed or refractory malignancies.”

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