MedPacto Seeks FDA Approval to Modify Vactosertib Dosing in Osteosarcoma Trial
核心洞察
MedPacto (搜索) has applied to the FDA for approval of dosing changes in its US Phase 1/2 trial of vactosertib monotherapy in osteosarcoma (搜索).
The open-label, multicenter study enrolls adolescents and adults with relapsed, refractory, or progressive osteosarcoma (搜索) and is run with Case Western Reserve University and UH Rainbow Babies and Children's Hospital (搜索).
The company plans to compare 200 mg twice daily and 300 mg twice daily to identify an optimal regimen, with Phase 2 assessing objective response rates and biomarker relationships.
MedPacto (搜索) has submitted an application to the U.S. Food and Drug Administration (搜索) seeking approval of changes to the dosing schedule of its U.S. Phase 1/2 clinical trial of vactosertib monotherapy in adolescents and adults with relapsed, refractory, or progressive osteosarcoma (搜索). The trial is open-label and multicenter, and is being conducted with Case Western Reserve University and UH Rainbow Babies and Children's Hospital (搜索).
The amended design compares 200 mg twice daily with 300 mg twice daily to identify an optimal regimen. Phase 1 is focused on determining the maximum tolerated dose and the recommended Phase 2 dose, while Phase 2 will evaluate objective response rates and biomarker relationships. Across both phases the study assesses safety, tolerability, pharmacokinetics, and antitumor activity.
MedPacto (搜索) noted the inherent risks of oncology drug development, stating that outcomes may not meet expectations and that commercialization plans could change as the study progresses in the United States, with related Korean trials advancing in parallel.