Crescent Biopharma said the Food and Drug Administration cleared its investigational new drug application for CR-002 to treat advanced solid tumors.
Chief Medical Officer Ellie Im on Monday said the clearance marks an important milestone for Crescent, as it means that the company can begin its trial--known as Apollo--for the drug.
"We look forward to initiating the Apollo trial this quarter and working with global investigators to generate important clinical insights and advance our mission of bringing new treatment options to patients living with difficult-to-treat cancers," Im said.
Crescent plans to study the treatment in patients with advanced solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and various gastrointestinal and gynecological tumors.
Initial clinical data from the trial is expected to be reported in the second half of 2027, the company said.