NCT04085185招募中1 期
A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 268
- 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 IBI110 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.
- •Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory to standard therapy, or for which no standard therapy exists.
- •Measurable disease according to RECIST Version 1.1 in solid tumor.
- •Subjects (women of child-bearing potential and males) must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least three months following the last dose of study drug. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
排除标准
- •Previous exposure to any anti-lag-3 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.
- •There were unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAE v5.0 induced by previous antitumor therapy (24 weeks before the first dose of study), and there were unrecovered immune-related adverse events (irAE) associated with immunotherapy.
- •Previous immunotherapy, such as anti-PD-1 / anti-PD-L1 antibody or anti-CTLA4 antibody, was discontinued due to the presence of > grade 3 irAE.
- •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
- •Present or history of pulmonary diseases such as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, pulmonary fibrosis, active pulmonary infection, severely impaired pulmonary function.
- •Positive human immunodeficiency virus (HIV) test.
- •Active hepatitis B or C, or tuberculosis.
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •History of gastrointestinal perforation and/or fistula at 6 months prior to study inclusion.
- •17.Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.
- •18.Known history of hypersensitivity to any components of the IBI110 or Sintilimab.
- •19.Uncontrolled complications of disease.
- •20.Other acute or chronic illness, mental illness, or abnormal laboratory test values that may increase the risk of study participation or administration of study drugs, or interfere with the interpretation of study results.
- •21.History of other primary malignancies.
- •Pregnant or nursing females.
研究组 & 干预措施
Phase Ia Dose-Escalation Stage:IBI110
Experimental
Participants will be treated with escalating doses of IBI110 to determine the MTD.
干预措施: IBI110 (Drug)
Phase Ia Expansion Stage:IBI110
Experimental
Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in different cancer types.
干预措施: IBI110 (Drug)
Phase Ib Dose-Escalation Stage:IBI110+ Sintilimab
Experimental
Participants will be treated with escalating doses of IBI110 in combination with a fixed dose of Sintilimab to determine the MTD.
干预措施: IBI110+ Sintilimab (Drug)
Phase Ib Expansion Stage:IBI110+ Sintilimab
Experimental
Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in combination with Sintilimab in different cancer types.
干预措施: IBI110+ 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 IBI110 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 IBI110 alone or in combination with Sintilimab.
次要结局
- Immunogenicity: Percentage of ADA positive subjects(up to 2 years after enrollment)
- Preliminary anti-tumor activity of IBI110 (Objective Response Rate)(up to 2 years after enrollment)
- Pharmacokinetics: Cmax(up to 2 years after enrollment)
- Pharmacokinetics: AUC(up to 2 years after enrollment)
研究者
研究点 (1)
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