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

Changchun GeneScience Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 82 人开始时间: 2025年6月10日最近更新: 2025年12月30日

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Changchun GeneScience Pharmaceutical Co., Ltd.
入组人数: 82
试验地点: 1
主要终点: Incidence and severity of adverse events (AEs) and dose limiting toxicities (DLTs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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 at least one measurable lesion by RECIST v1.1
•Has an ECOG status of 0 or 1
•Has a life expectancy of ≥ 3 months.

排除标准

•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 GenSci
•Has a history of leptomeningeal disease or spinal cord compression.
•Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci
•Has active infection requiring intravenous (IV) antibiotics or other uncontrolled inter-current illness requiring hospitalization. Minor infections, e.g., periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed.
•Uncontrolled hypertension (Blood pressure ≥ 150/90 mmHg despite optimal medical management)
•Has a history of prior organ transplant or allogeneic stem cell transplant.
•Has received a selective reactivator of p53 Y220C mutation.
•Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
•Has known human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibodies) or known chronic hepatitis B or C [participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA; participants positive for hepatitis C virus (HCV) IgG will be eligible if they are negative for HCV-RNA].
•Is persisting toxicity related to prior anticancer therapy (NCI CTCAE V5.0 Grade>1). However, alopecia and sensory neuropathy Grade ≤2, or other Grade ≤2 adverse events not constituting a safety risk, based on the investigator's judgment are acceptable.
•Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or GenSci128 administration or may interfere with the interpretation of study results, in the judgment of the investigator, would make the participant inappropriate for entry into this study.