A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 10
- 主要终点
- MTD or RP2D of IBI129
研究概览
简要总结
This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2
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
- •Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- •At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
- •Male or female subjects ≥ 18 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- •Anticipated life expectancy of ≥ 12 weeks;
- •Adequate bone marrow and organ function
排除标准
- •Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
- •Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter.
- •Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
- •Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
- •Known symptomatic central nervous system (CNS) metastases.
研究组 & 干预措施
IBI129
IBI129
干预措施: IBI129 (Drug)
结局指标
主要结局
MTD or RP2D of IBI129
时间窗: 12 months
Number of subjects with dose-limiting toxicities (DLTs)
Number of subjects with adverse events
时间窗: 24 months
Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
Number of subjects with clinically significant changes in physical examination results
时间窗: 24 months
Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
时间窗: 24 months
Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
次要结局
- Volume of distribution (V) of IBI129(12 months)
- Duration of response (DoR)(24 months)
- Progression free survival (PFS)(24 months)
- Area under the curve (AUC) of IBI129(12 months)
- Plasma concentration (Cmax) of IBI129(12 months)
- Time to maximum concentration (Tmax) of IBI129(12 months)
- Immunogenicity of IBI129(12 months)
- Clearance (CL) of IBI129(12 months)
- Half-life (T1/2) of IBI129(12 months)
- Objective response rate (ORR)(24 months)
- Time to response (TTR)(24 months)
- Disease control rate (DCR)(24 months)
- Overall survival (OS)(24 months)