A Phase I Study to Assess the Safety, Tolerability and Biomarker Profiles of CBA-1535, Recombinant Protein Tribody in Patients With Previously Treated Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535.
The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab.
This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.
详细描述
To evaluate safety and efficacy of CBA-1535 in the following two parts in a stepwise manner:
Part 1
- In Part 1, the primary objective is to evaluate the safety and tolerability of CBA-1535 in patients with solid tumors where no standard treatment is available, or who are intolerant to or non-responders to standard treatments.
Additionally, the PK, biomarker profiles, and preliminary efficacy will be evaluated. The initial dose for Part 2 will also be determined.
Part 2
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who provide voluntary written informed consent to participate in the study
- •ECOG performance status: <= 1
- •Patients with 3 months or longer life expectancy
- •Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy
排除标准
- •Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment
- •Patients who received anti-cancer drug within 14 days prior to enrollment
- •Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug
研究组 & 干预措施
Part 1: CBA-1535 (single agent therapy)
Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle.
干预措施: CBA-1535 (Drug)
Part 2: CBA-1535+Pembrolizumab
Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle.
干预措施: CBA-1535+Pembrolizumab (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: Up to 21 days in Cycle 1
DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days).
Adverse event
时间窗: Up to approximately 24 months
An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, regardless of whether or not it is related to the investigational product.
次要结局
- Serum CBA-1535 concentration(From Day 1 to Day 22)
- Efficacy in previously treated advanced solid Tumors.(Up to approximately 24 months.)