A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Dose limiting toxicities (DLTs)
研究概览
简要总结
This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).
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;
- •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.
- •Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
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;
- •Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate.
- •Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).
研究组 & 干预措施
Open-label：IBI133 monotherapy
干预措施: IBI133 (Biological)
结局指标
主要结局
Dose limiting toxicities (DLTs)
时间窗: 21 days after the first dose of IBI133
DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD)and /or recommended phase 2 dose (RP2D)
Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)
时间窗: Up to 90 days after the last administration
Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0
次要结局
- half-life (T1/2)(Up to 2 years)
- maximum concentration (Cmax)(Up to 2 years)
- anti-drug antibody (ADA)(Up to 2 years)
- Preliminary efficacy including objective response rate (ORR)(Through study completion,Up to 2 years)
- progression free survival (PFS)(Through study completion,Up to 2 years)
- area under the curve (AUC)(Up to 2 years)
- clearance rate(CL)(Up to 2 years)
- duration of response (DoR)(Through study completion,Up to 2 years)
- ,time to response (TTR)(Through study completion,Up to 2 years)
- disease control rate (DCR)(Through study completion,Up to 2 years)