MedPacto amends Vactosertib osteosarcoma Phase 2 clinical trial

MedPacto has received approval from the Ministry of Food and Drug Safety to amend its Phase 2 clinical trial protocol for Vactosertib, a candidate drug targeting recurrent, refractory, or advanced osteosarcoma.

The amendment introduces a medium-dose group to the existing high-dose study. Specifically, the trial will now compare a 200mg BID (twice daily) dose—with 150mg BID for adolescents—against the current 300mg BID high-dose group. This change aims to precisely evaluate the correlation between dosage and response to determine the optimal dose for subsequent clinical stages.

The multi-center clinical trials are being conducted simultaneously in South Korea and the United States, with the Korean portion involving seven hospitals, including Korea Cancer Center Hospital. The study is scheduled to continue through February 2028. MedPacto plans to apply for a similar amendment with the U.S. Food and Drug Administration (FDA) in the future.