SY-9453 / Shouyao Holdings - LARVOL DELTA

A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=122 | Recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • MTAP

Development of SY-9453, a novel MAT2A inhibitor, for the treatment of MTAP-deficient cancers (AACR 2025) - "The encouraging clinical activity of IDE397 provides further proof-of-concept for MAT2A inhibitors in the treatment of MTAP-deficient cancers. Furthermore, SY-9453 revealed favorable PK properties and tolerability in preclinical studies. In conclusion, the current results demonstrate that SY-9453 is a novel small molecule MAT2A inhibitor with high activity in vitro and in vivo, providing a rational option for treating cancers with MTAP deficiency."

Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDKN2A • MAT2A • MTAP

A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=122 | Not yet recruiting | Sponsor: Shouyao Holdings (Beijing) Co. LTD

New P1 trial • Oncology • Solid Tumor • MTAP

Shouyao Holdings (Beijing)…announced that the National Medical Products Administration (NMPA) has approved a clinical study for SY-9453 in patients with locally advanced or metastatic solid tumors harboring homozygous deletion of methylthioadenosine phosphorylase (MTAP) (flcube.com) - "Next Steps: Phase I/II trial initiation expected Q2 2026."

New P1/2 trial • Solid Tumor