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

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.”