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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

October 31, 2028

Conditions
Solid Tumors Harboring a TP53 Y220C Mutation
Interventions
DRUG

GenSci128 tablets

GenSci128 tablets have three specifications, including 50mg, 200mg, 500mg, and are taken in combination with the doctor's advice in different dose levels. GenSci128 will be orally administrated daily (except single dose in Cycle 0) with no interruptions until occurrence of unacceptable toxicity, or progressive disease, or withdrawal of consent, or death, or contact lost, or starting a new anticancer therapy, etc. (whichever occurs first).

Trial Locations (1)

200032

Zhongshan Hospital ,Fudan University, Shanghai

All Listed Sponsors
lead

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY