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
Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci128 and any study procedures)
Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures
Has confirmed TP53 Y220C mutation in tumor tissue
Has histologically or cytologically confirmed locally advanced or metastatic solid tumors and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.
Has diagnosed as primary central nervous system (CNS) tumor.
Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of GenSci128.
Has a history of leptomeningeal disease or spinal cord compression.
Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.
Single group
GenSci128 tablets
DrugGenSci128 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).
6
Treatment groupsSee each treatment group below.
Incidence and severity of adverse events (AEs) and dose limiting toxicities (DLTs)
Part 1 is a dose escalation study ，to assess the safety and tolerability of GenSci128 in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation
maximal tolerance dose （MTD）、recommended dose of expansion （RDE）
Part 1 is a dose escalation study ，to determine the maximum tolerated dose (MTD), if any, and recommend dose of expansion (RDE) for GenSci128 in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation
recommended phase 2 dose （RP2D）
Part 2 is a dose expansion study，Determining Recommended Phase II Dose
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