GenSci128
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March 12, 2026
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
December 31, 2025
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
August 07, 2025
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
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