An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced HCC and Other Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 67
- 主要终点
- Part1:Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration
研究概览
简要总结
This is an open-label, multi-center phase 1 study. The trial, consisting of Part
1 dose confirmation and Part 2 dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with Toripalimab in patients with advanced HCC and other solid tumors.
详细描述
subjects will be treated with HBM4003 in combination with Toripalimab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first.
This trial consists of :
- A screening period: 28 days
- A treatment period:
- Part 1 dose confirmation study
- Part 2 dose expansion study
- A post-treatment follow-up period, including
- A safety follow-up period: 28 days after the last dose of study drug;
- Post-treatment follow-up visit: day 84 after the last dose of study drug;
- Survival follow-up.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HBM4003+Toripalimap
HBM4003 combined with toripalimab in patients with advanced HCC and other solid tumors
干预措施: HBM4003 and Triprilimab (Drug)
结局指标
主要结局
Part1:Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration
时间窗: approximate 21 days
Number of subjects who experience DLT events
Part1:The maximum tolerated dose (MTD) of HBM4003 combined with toripalimab
时间窗: approximate 21 days
Part1:Recommended Phase 2 dose (RP2D) of HBM4003 combined with toripalimab
时间窗: approximate 21 days
Part2:ORR, as determined by the Investigator using RECIST 1.1
时间窗: maximum 2 years
Proportion of subjects with complete response (CR) and partial response (PR)
次要结局
- Part 1: Duration of Disease Control, DDC, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- Part2: Duration of Response, DOR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- Part 2: Progression-free survival (PFS)(maximum 2 years)
- Part 1:ORR, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC(maximum 2 years])
- Part 1: Disease Control Rate, DCR, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- Tmax(maximum 2 years)
- AUC0-tau(maximum 2 years)
- Part 2: Overall survival (OS)(maximum 2 years)
- Part 1: Duration of Response, DOR, as determined by the Investigator using RECIST 1.1 for solid tumors, using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- Part2: ORR, as determined by the Investigator using mRECIST for HCC(maximum 2 years)
- Part 2: Disease Control Rate, DCR, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- Cmax(maximum 2 years)
- AUC0-last(maximum 2 years)
- Part2:Duration of Disease Control, DDC, as determined by the Investigator using RECIST 1.1 and mRECIST for HCC(maximum 2 years)
- The immunogenicity of HBM4003 and Triprilimab(maximum 2 years)