NCT03875157已完成1 期
To Evaluate the Safety, Tolerability, and Initial Efficacy of IBI318 in Patients With Advanced Malignancy, Multicenter, IA/IB Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Number of participants experiencing clinical and laboratory adverse events (AEs)
研究概览
简要总结
An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancies.
详细描述
An open label, multicenter, phase Ia/Ib study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form
- •Men or women 18 years or older
- •Expected survival time ≥ 12 weeks
- •Tumor assessment according to RECIST v1.1, at least one measurable lesion
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Have adequate organ and bone marrow function
- •Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
- •Female subjects must not be pregnant or breastfeeding. If premenopausal, negative urine or serum pregnancy tests are required
- •Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and are refractory or intolerant to existing standard treatments
- •Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer, or other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia
排除标准
- •Previous exposure to immunotherapy including but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
- •Participation in another interventional clinical study, an observational (non-interventional) clinical study, or a follow-up phase of an interventional study
- •Receive last anti-tumor treatment within 4 weeks prior to the first dose of study drug
- •Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
- •Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
- •Toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v 5.0 level 0-1 within 4 weeks prior to the first dose of study drug
- •Received major surgery or has unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug
- •Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
- •History of infectious pneumonitis that required steroids or has current pneumonitis
- •Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
- •Active autoimmune disease that has required systemic treatment in past 2 years
- •Known active Hepatitis B or Hepatitis C virus
- •Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that could affect study compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent
- •Known history of human immunodeficiency virus (HIV) infection
- •Known history of active tuberculosis (TB) or active syphilis
- •History of allogeneic organ transplantation or hematopoietic stem cell transplantation
- •Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
- •Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
- •Female subjects who are pregnant or lactating
结局指标
主要结局
Number of participants experiencing clinical and laboratory adverse events (AEs)
时间窗: Up to 90 days post last dose
Number of all study participants who demonstrate a tumor response
时间窗: up to 24 months
Number of participants experiencing dose-limiting toxicities (DLTs)
时间窗: 28 days within first dose in phase Ia
次要结局
- Positive rate of ADA and Nab(Up to 90 days post last dose)
- The area under the curve (AUC) of plasma concentration of drug against time after administration of IBI318(Up to 90 days post last dose)
- Time at which maximum concentration (Tmax) occurs for IBI318(Up to 90 days post last dose)
- Maximum concentration (Cmax) after first dose interval of IBI318(Up to 90 days post last dose)
- The half-life (t1/2) of IBI318 in plasma(Up to 90 days post last dose)
研究者
研究点 (1)
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