NCT05183243招募中1 期
A Multicenter, Open-label Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GH21 Capsules in Subjects With Advanced Solid Tumors
Suzhou Genhouse Bio Co., Ltd.9 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年2月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 9
- 主要终点
- Determination of Maximum Tolerated Dose (MTD) of GH21.
研究概览
简要总结
Evaluate the safety and tolerability of GH21 in patients with advanced solid tumors.
Estimate the maximum tolerated dose (MTD) in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female subjects greater than or equal to 18 years old；
- •Written informed consent obtained prior to any study-related procedure being performed;
- •Subjects with life expectancy ≥3 months;
- •Eastern Cooperative Oncology Group performance score 0 - 2;
- •Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor;
- •At least one measurable lesion based on RECIST version 1.1 .
排除标准
- •History of other malignancies within 3 years before screening,unless radical non-melanoma skin cancer or basal cell carcinoma of the skin or carcinoma in the situ of the cervix;
- •Have central nervous system metastases;
- •Prior treatment with SHP2 inhibitor;
- •Have major surgery within 28 days prior to the first dose of GH21;
- •Left ventricular ejection fraction (LVEF) <50 %;
- •Females who are pregnant or breastfeeding ;
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- •Conditions that the investigator considers inappropriate for participation in this clinical trial.
研究组 & 干预措施
Monotherapy Dose Escalation.
Experimental
Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.
干预措施: GH21 Capsule (Drug)
结局指标
主要结局
Determination of Maximum Tolerated Dose (MTD) of GH21.
时间窗: 28 Days
MTD is the highest dose of a treatment that does not cause unacceptable side effects.
Characterize the Safety of GH21
时间窗: Approximately 3 years
Number of participants with treatment-emergent adverse events and serious AEs.
次要结局
- Tmax(Approximately 3 years)
- Objective Response Rate (ORR)(Approximately 3 years)
- Disease Control Rate (DCR)(Approximately 3 years)
- Duration of Response (DOR)(Approximately 3 years)
- Progression-Free Survival (PFS)(Approximately 3 years)
- PD of GH21(Approximately 3 years)
- Cmax(Approximately 3 years)
- T1/2(Approximately 3 years)
研究者
研究点 (9)
Loading locations...
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