A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of subjects with AEs and SAEs
研究概览
简要总结
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies
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
- •Able to understand and willing to sign the ICF.
- •Adults 18 years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy at least 12 weeks.
- •Adequate organ and bone marrow function.
- •Eligibility Criteria：
- •Previous exposure to any anti-TIGIT antibody.
- •Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
- •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.
- •Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
- •Medication requiring long-term systemic hormones or any other immunosuppression therapy.
- •Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
- •Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
- •History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- •Positive human immunodeficiency virus (HIV) test.
- •Active hepatitis B or C, or tuberculosis.
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •Known history of hypersensitivity to any components of the IBI939 or Sintilimab.
- •Pregnant or nursing females.
排除标准
- 未提供
研究组 & 干预措施
Phase Ia Dose-Escalation Stage:IBI939
Participants will be treated with escalating doses of IBI939 to determine the MTD.
干预措施: IBI939 (Drug)
Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab
Participants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD.
干预措施: IBI939+ Sintilimab (Drug)
Phase Ib Expansion Stage:IBI939+ Sintilimab
Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI939 in combination with Sintilimab in different cancer types.
干预措施: IBI939+ Sintilimab (Drug)
结局指标
主要结局
Number of subjects with AEs and SAEs
时间窗: up to 2 years after enrollment
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: From Baseline to the end of Cycle 1
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.
次要结局
- Pharmacokinetics: AUC(up to 2 years after enrollment)
- Pharmacokinetics: Cmax(up to 2 years after enrollment)
- Immunogenicity: Percentage of ADA positive subjects(up to 2 years after enrollment)
- Preliminary anti-tumor activity (Objective Response Rate)(up to 2 years after enrollment)