A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Hutchmed
- 入组人数
- 147
- 试验地点
- 7
- 主要终点
- DLTs
研究概览
简要总结
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:
Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.
Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.
详细描述
Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.
Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (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
- •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
- •History of inflammatory gastrointestinal diseases
- •Known hypersensitivity to any component of HMPL-A830
- •Pregnant (positive pregnancy test) or lactating;
结局指标
主要结局
DLTs
时间窗: Approximately 12 months
Number of Participants With of DLTs
Overview of Treatment-emergent Adverse Events (TEAEs)
时间窗: Approximately 12 months
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Objective Response Rate (ORR)
时间窗: Approximately 24 months
Assessed by investigators according to RECIST 1.1
Recommended doses for phase II or III studies (RP2D or RP3D)
时间窗: Approximately 12 months
The RP2D or RP3D will be selected by evaluating all available data from the following criteria under consideration: Determination of MTD achieved during the dose escalation part; Safety data obtained across all different doses tested; Tolerability data; PK data; efficacy data.
次要结局
- Disease control rate (DCR)(Approximately 2 years)
- Progression-free survival (PFS)(Approximately 2 years)
- Pharmacokinetic Analysis(Cmax)(Approximately 2 years)
- Pharmacokinetic Analysis (Cmin)(Approximately 2 years)
- Pharmacokinetic Analysis(Tmax)(Approximately 2 years)
- Pharmacokinetic Analysis((AUClast)(Approximately 2 years)
- Pharmacokinetic Analysis((AUCtau)(Approximately 2 years)
- Incidence of anti-drug antibodies (ADAs) against HMPL-A830(Approximately 2 years)