A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety and tolerance
研究概览
简要总结
This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors
详细描述
Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Provide signed informed consent;
- •Male or female aged at 18-75 (inclusive) years;
- •Expected survival ≥12 weeks;
- •ECOG PS score 0 or 1;
- •Provide archival or fresh tissues for CLDN18.2 expression analysis;
- •Adequate laboratory parameters;
- •Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
- •Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
- •Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors
排除标准
- •The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
- •The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
- •Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
- •The subjects with history of hypersensitivity to the study drug;
- •The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
- •The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
- •The subjects with pyloric obstruction;
- •The subjects with active or poorly controlled serious infections
研究组 & 干预措施
IBI360
干预措施: IBI 360 Injection (Drug)
IBI 360 + Sintilimab
干预措施: IBI 360 Injection Sintilimab (Drug)
结局指标
主要结局
Safety and tolerance
时间窗: up to 90 days following last dose
Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Recommended Phase 2 Dose (RP2D)
时间窗: up to 21 days following last dose level
A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data
次要结局
- Efficacy(Subjects were randomized 6 months and 1 year later)
- Pharmacokinetics(Up to 48 weeks following first dose)
- Immunogenicity(up to 90 days following last dose)