Qurient Co. Ltd. announced that the first patient has been dosed in the Phase 1/2 dose-escalation and expansion study of Q901 in patients with advanced solid tumors. The Q901 Phase 1/2 study (NCT05394103) is being conducted at six investigative sites in the U.S., and approximately 70 patients with advanced solid tumors are scheduled to be enrolled.

The primary objectives of the Phase 1/2 study are to determine the maximum tolerated dose, safety profile, and anticancer efficacy of Q901. Q901 is a highly selective CDK7 inhibitor that disrupts tumor cells division cycle progression and blocks DNA damage repair, resulting in tumor cell apoptosis. The genomic instability triggered by Q901 not only contributes to cell death but also provokes immune surveillance against tumor cells.

Q901 is the company’s second oncology drug candidate being developed to treat patients with advanced solid tumors. In preclinical studies, Q901 has demonstrated a high level of tumor growth inhibition activity as a monotherapy in a variety of tumor models, including prostate, pancreatic, colorectal, and breast cancers, that do not respond to conventional therapies. Q901 also has substantial activity in other preclinical cancer models where CDK4/6 cell cycle inhibitors have minimal or reduced activity.