Stamford-based Loxo Oncology Inc., a biopharmaceutical company developing medicines for patients with genetically defined cancers, Tuesday announced the enrollment of the first patient in its Phase 1 trial of LOXO-101 in pediatric patients with advanced solid or primary central nervous system (CNS) tumors.
LOXO-101 is the only selective inhibitor of the tropomyosin receptor kinase (TRK) protein family in clinical development, according to a news release from the company.
“Given the promising early efficacy and tolerability results we have seen in adults with TRK fusion cancers, we are excited to explore the potential of LOXO-101 in children and adolescents with cancer,” Dr. Josh Bilenker, CEO of Loxo Oncology, said in the release. “The TRK pathway has been implicated in many pediatric cancers, and this trial is an important step toward understanding LOXO-101 in these settings.”
To enroll in the trial, patients must be between 1 and 21 years old with a locally advanced or metastatic solid tumor or primary CNS tumor that has progressed, or was nonresponsive to available therapies, and for which no standard or available curative therapy exists.
Patients at least 1 month old are eligible for enrollment if they have a diagnosis of infantile/congenital fibrosarcoma, with a documented NTRK fusion that has progressed, or was nonresponsive to available therapies, and for whom no standard or available curative therapy exists.
