A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Hutchmed
- 入组人数
- 186
- 试验地点
- 21
- 主要终点
- Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE)
研究概览
简要总结
This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.
详细描述
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of HMPL-A580 in solid tumors.
To characterize the safety, tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) to determine recommended dose(s) for phase 2 dose (RP2D) or phase 3 dose (RP3D) in participants with selected solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Understood this study and are able to voluntarily sign the informed consent form (ICF);
- •Male or Female, Age ≥ 18 years;
- •Histological confirmed, unresectable, advanced or metastatic solid tumor
- •Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- •Life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
排除标准
- •An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
- •Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
- •Major surgery within 28 days prior to the first dose of study drug
- •Active infection requiring systemic treatment
- •Participant has received a live within 3 months before study enrollment
- •History of inflammatory gastrointestinal diseases
- •Known hypersensitivity to any component of HMPL-A580
- •Pregnant (positive pregnancy test) or lactating;
研究组 & 干预措施
Part A(Phase I) Dose Escalation
干预措施: HMPL-A580 (Drug)
Part B(Phase IIa) Dose Expansion/Dose Optimization
干预措施: HMPL-A580 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and/or recommended dose(s) for expansion(RDE)
时间窗: Approximately 12 months
To evaluate the safety, tolerability, and MTD) and/or RDE of HMPL-A580 in solid tumors
Overview of Treatment-emergent Adverse Events (TEAEs)
时间窗: Approximately 12 months
To characterize the safety of HMPL-A580 at RDE(s)
Objective Response Rate (ORR)
时间窗: At least 8 weeks post dose of first participant up to approximately 24 months
To characterize the tolerability, and preliminary efficacy of HMPL-A580 at RDE(s)
Recommended doses for phase II or III studies (RP2D or RP3D) of HMPL-A580
时间窗: Approximately 12 months
To characterize the safety, tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) to determine recommended dose(s) for phase 2 dose (RP2D) or phase 3 dose (RP3D) in participants with selected solid tumors.
次要结局
- disease control rate (DCR)(Approximately 2 years)
- progression-free survival (PFS)(Approximately 2 years)