An Open Phase I Study to Evaluate the Safety, Tolerability, PK / PD, and Initial Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced Melanoma and Other Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 61
- 主要终点
- Prat 1 :MTD
研究概览
简要总结
HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.
详细描述
An open-label Phase 1 study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors.
The study is composed of two part, part 1 will be approximately 31subjects and Part 2 will be approximately 30 subjects.
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 melanoma and other solid tumors
干预措施: HBM4003 and Triprilimab (Drug)
结局指标
主要结局
Prat 1 :MTD
时间窗: approximate 42 days
The maximum tolerated dose (MTD) of HBM4003 combined with toripalimab
Prat 1 :RP2D
时间窗: approximate 42 days
Recommended Phase 2 dose (RP2D) of HBM4003 combined with toripalimab
Part 2:ORR
时间窗: maximum 3 years
Proportion of patients with complete response (CR) and partial response (PR)
Part 1:Number of subjects with DLT in each dose group within 2 cycles (42 days) after the first trial administration
时间窗: approximate 42 days
DLT observation period was defined as two treatment cycles with a total of 42 days,including 21 days in the first cycle (HBM4003 single drug treatment cycle) and 21 days in the second cycle (HBM4003 combined with triprilimab treatment cycle).
次要结局
- AUC0-tau (Area under the serum concentration versus time curve from time zero to the dosing interval tau(maximum 3 years)
- Part 2:DCR(maximum 3 years)
- AUC0-last(maximum 3 years)
- The immunogenicity of HBM4003 and Triprilimab(maximum 3 years)
- Prat 2:OS(maximum 3 years)
- Part 1:Duration of Response, DOR(maximum 3 years)
- Cmax (Maximum serum concentration)(maximum 3 years)
- Tmax (Time to reach maximum serum concentration)(maximum 3 years)
- Prat 2:The immunogenicity of HBM4003 and Triprilimab(maximum 3 years)
- Part 1:ORR(maximum 3 years)
- Part 1:Disease Control Rate，DCR(maximum 3 years)
- Part 1:Duration of Disease Control, DDC(maximum 3 years)
- Part 2:DDC(maximum 3 years)
- Part 2:DOR(maximum 3 years)
- Part 2:PFS(maximum 3 years)