InnoCare Pharma announced that the first adolescent patient has been dosed in clinical trial with its second generation pan-TRK inhibitor ICP-723 at the Sun Yat-sen University Cancer Center. This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent (12 to 18 years old) patients after showing good safety and efficacy in adult patients.
ICP-723 was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, sarcoma, etc., and for patients resistant to the first generation of TRK inhibitors.
Among the adult patients with NTRK fusion treated at the recommended Phase II dose (RP2D), ICP-723 showed good efficacy and safety. After the clinical study performed in adolescent patients for the first time, InnoCare will also expand ICP-723 to treat pediatric patients (2 to 12 years old).
Based on the Proof-of-Concept (POC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China. The Company has also conducted a clinical study of ICP-723 in the United States. Currently there was no dose-limiting toxicities (DLTs) observed at the first dose group.
Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, said, “NTRK gene fusion occurs in adult, adolescent and pediatric cancers, especially among adolescent and pediatric patients. InnoCare will accelerate the clinical trials to meet their unmet clinical needs.”