A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of CSPCHA131 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
研究概览
简要总结
The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors.
详细描述
This is a dose escalation and expansion study with the aim to evaluate and characterize the tolerability and safety profile of CSPCHA131 alone (Stage I) or plus chemotherapy (Stage II) in patients with advanced solid tumors.
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
- •1.18-75 years of age.
- •Histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumors, for which standard therapy either does not exist or has been proven ineffective or intolerable for the patient.
- •At least one measurable tumor lesion according to RECIST version 1.
- •ECOG performance status of 0 or
- •Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline.
排除标准
- •Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, other anti-tumor treatments or an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
- •Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure.
- •Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less.
- •Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment.
- •Active infections of grade 2 or above.
- •Peripheral neuropathy of grade 2 or above.
研究组 & 干预措施
CSPCH131 dose Escalation and expansion
In the dose escalation part of Stage I, five dose levels will be tested according to the "3 + 3" dose-escalation design. Whether and how to carry out the follow-up study parts will be decided by the PI and sponsor on the basis of the achieved results of safety, tolerability and effectiveness of CSPCHA131.
干预措施: CSPCHA131 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
时间窗: Time Frame: 28 days
Incidence of adverse events (AEs) and serious adverse events throughout the trial;
时间窗: from enrollment to the end of the trial (2 years)
次要结局
- Cmax(28 days)
- Css_min(28 days)
- Objective response rate (ORR) defined by RECIST Criteria Version 1.1;(from enrollment to the end of the trial (2 years))
- Css_max(28 days)
- Progression free survival (PFS) defined by RECIST Criteria Version 1.1;(from enrollment to the end of the trial (2 years))
- AUC0-t(28 days)
- AUC0-∞(28 days)
- Ke(28 days)
- DF(28 days)
- Vz(28 days)
- T1/2(28 days)
- CL(28 days)
- Tmax(28 days)