GenSci128 / GeneScience - LARVOL DELTA

GS-P-328, a brain-penetrant small molecule p53 Y220C reactivator for tumors harboring p53 Y220C mutation (AACR 2024) - "The initial clinical evaluation of PC14586 that can restore missense-mutant p53 protein has seen efficacy in patients harboring p53 Y220C mutation even though there is still room for improvement. GS-P-328 has a favorable ADME profile in rodents, dogs and NHPs, as well as a much better safety profile. GS-P-328 is now under IND-enabling study and P1 study is planned in early 2025."

Lung Cancer • Oncology • Solid Tumor • CDKN1A • MDM2

Changchun GeneScience Pharmaceutical Inc. announced that GenSci128 tablets, its independently developed selective TP53 Y220C mutation reactivator, has received U.S. FDA Orphan Drug Designation (ODD) for the treatment of pancreatic cancer (flcube.com)

Orphan drug • Pancreatic Cancer

A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Solid Tumor

A Phase I, Multicenter, Multinational, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (ChiCTR) - P1 | N=82 | Not yet recruiting | Sponsor: Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

New P1 trial • Solid Tumor • KRAS • TP53