NCT05886374招募中1 期
A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-415S1 in Patients With Advanced Malignant Solid Tumor
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
- Hutchmed
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of HMPL-415S1 as a single oral agent in advanced malignant solid tumor
研究概览
简要总结
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.
详细描述
This study is expected to enroll 36-81 patients, including 26-66 patients for dose escalation, additional 10-15 patients will be enrolled at the dose level of determined RP2D.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the following conditions must be met for enrollment:
- •Fully understand this study and voluntarily sign the ICF;
- •Dose escalation Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons; Dose expansion phase: Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons, carrying aberrant activating mutations in the KRAS pathway；
- •Presence of at least one measurable lesion (RECIST 1.1 criteria);
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 point;
- •Life expectancy ≥ 12 weeks as judged by the investigator;
- •Male of childbearing potential and their heterosexual partners of childbearing potential must agree to use effective methods of contraception.
排除标准
- •A patient may not participate in this study if any of the following conditions apply:
- •Patients who priorly received SHP2 inhibitors;
- •Receiving the approved systemic antitumor treatment within 4 weeks prior to the first dose, including: chemotreatment, targeted treatment, immunization treatment, biological treatment, etc. (wash-out for 2 weeks for hormone treatment or traditional chinese medicine and chinese patent medicine with clear antitumor indications);
- •Have been in the treatment period of other interventional clinical studies (including small molecule chemicals and large molecule antibodies) within 4 weeks prior to the first dose. If participating in a non-interventional clinical study (eg, epidemiological study), you can enroll in this study; if already in the survival follow-up period of an interventional clinical study, you can enroll in this study.
- •Major surgery or radical radiotreatment (except palliative radiotreatment for metastases to bone lesions) within 4 weeks prior to first dose.
- •Central nervous system (CNS) malignant tumor or known CNS metastasis;
- •Having multiple factors that affect the absorption, distribution, metabolism or excretion of orally administered drugs (such as inability to swallow drugs, frequent vomiting, chronic diarrhoea, etc.);
- •Any other disease, metabolic abnormality, physical examination abnormal, or clinically significant laboratory test abnormality that, in the judgment of the investigator, would compromise patient compliance or give reason to suspect that the patient has a disease or condition that would compromise the interpretation of study results or place the patient at high risk.
研究组 & 干预措施
HMPL-415S1
Experimental
HMPL-415S1 will be administered orally once daily in 28 days treatment cycles
干预措施: HMPL-415S1 (Drug)
结局指标
主要结局
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of HMPL-415S1 as a single oral agent in advanced malignant solid tumor
时间窗: from Cycle 0Day1 up to Cycle1Day28 (each cycle is 28 days).
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
次要结局
- AUC(0-tlast) (Cycle 0 ) of HMPL-415S1(from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).)
- To investigate the pharmacokinetic (PK) profile of oral HMPL-415S1(from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).)
- Disease control rate (DCR)(From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).)
- uration of response (DoR)(From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).)
- Progression-free survival (PFS)(From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).)
- AUCinf (Cycle 0 ) of HMPL-415S1(from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).)
- Objective Response Rate (ORR)(From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).)
- Time to response (TTR)(From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).)
- Overall survival (OS)(From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).)
研究者
研究点 (1)
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