A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IBI323 in Participants With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability and efficacy of IBI323(anti-LAG-3/PD-L1) or in combination with chemotherapy in participants with advanced malignancies. Another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of IBI323
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
- •Phase Ia Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment Phase Ib cohort A Patients with IO-refractory advanced NSCLC cohort B Patients with IO-naive advanced NSCLC who have failed standard treatment cohort C Patients with advanced NSCLC who have no prior treatment and PD-L1 TPS≥1% cohort D Patients with ES-SCLC or G3 neuroendocrine tumors who have failed standard treatment cohort E Patients with advanced MPM who have failed standard treatment cohort F Patients with advanced UC who have failed standard treatment cohort G Patients with advanced nccRCC who have failed standard treatment cohort H Patients with advanced HCC who have failed standard treatment cohort I Patients with advanced NPC who have failed standard treatment cohort J Patients with advanced CC or HNSCC who have failed standard treatment cohort K Patients with advanced GC or GEJC with HER2 negative who have no prior treatment cohort L Patients with advanced TNBC who have failed standard treatment
- •Able to understand and willing to sign the ICF.
- •18 to 75 years old.
- •Life expectancy at least 12 weeks.
- •At least 1 measurable lesion per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ and bone marrow functionAdequate organ and bone marrow function.
排除标准
- •Prior treatment with any anti- LAG-3 antibody.
- •Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
- •Any investigational drugs received within 4 weeks prior to the first study treatment.
- •Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- •Symptomatic CNS metastasis.
- •History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- •Pregnant or nursing females.
研究组 & 干预措施
IBI323
Phase Ia enrolls patients with advanced malignancies. Phase Ib cohort A enrolls patients with NSCLC(IO-refractory), cohort B NSCLC(IO-naive), cohort C NSCLC(PD-L1 TPS≥1%), cohort D ES-SCLC or neuroendocrine tumors, cohort E MPM, cohort F UC, cohort G nccRCC, cohort H HCC, cohort I NPC, cohort J CC or HNSCC, cohort K GC or GEJC with HER2 negative, cohort L TNBC
干预措施: IBI323 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: 24 months
To evaluate the safety and tolerability of IBI323 \[Adverse events (AEs), treatment-related AE (TRAE), immune-related AEs (irAE), serious adverse event (SAE), dose-limiting toxicity (DLT) assessed by CTCAE v5.0\]
次要结局
- Disease Control Rate(DCR)(24 months)
- Anti-drug antibody (ADA)(24 months)
- Investigator Assessments of Overall Response Rate(ORR)(24 months)
- PFS (progression-free survival)(24 months)