A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation

Phase 1 Recruiting 82 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is 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

Timeline

Start: 2025-06-10
Primary completion: 2027-12
Completion: 2028-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GenSci128	Unknown	150 mg	Oral
Subject	GenSci128	Unknown	300 mg	Oral
Subject	GenSci128	Unknown	600 mg	Oral
Subject	GenSci128	Unknown	1200 mg	Oral
Subject	GenSci128	Unknown	1800 mg	Oral
Subject	GenSci128	Unknown	2500 mg	Oral

Indications

No indication recorded.