Phase 1 Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in the First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 15
- 主要终点
- Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC
研究概览
简要总结
This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Able to sign a written consent form, understand, and agree to comply with requirements of the study.
- •Documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
- •No prior systemic treatment for advanced or metastatic NSCLC, including but not limited to chemotherapy or targeted therapy.
- •At least one measurable lesion as assessed by RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) PS ≤
- •Adequate organ function as indicated by laboratory tests.
排除标准
- •Participants diagnosed with NSCLC that harbor a driver mutation (eg, EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1 mutation).
- •Participant has received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before first dose of study drug.
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- •Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •Any cancer ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix or breast).
- •Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part 1: Dose/Injection Site Exploration
Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype.
干预措施: Histology-Based Chemotherapy Doublet (Drug)
Part 2: Dose Expansion
The recommended dose of tislelizumab SC determined from Part 1 plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype will be evaluated.
干预措施: Histology-Based Chemotherapy Doublet (Drug)
Part 1: Dose/Injection Site Exploration
Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype.
干预措施: Tislelizumab SC (Drug)
Part 2: Dose Expansion
The recommended dose of tislelizumab SC determined from Part 1 plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype will be evaluated.
干预措施: Tislelizumab SC (Drug)
Part 1: Dose/Injection Site Exploration
Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype.
干预措施: Tislelizumab IV (Drug)
结局指标
主要结局
Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC
时间窗: Up to approximately 3.5 months
Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC
时间窗: Up to approximately 3.5 months
Part 1: Bioavailability of Tislelizumab SC
时间窗: Up to approximately 2 months
Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC
时间窗: Up to approximately 3.5 months
Part 2: Accumulation ratio (Rac) of Tislelizumab SC
时间窗: Up to approximately 3.5 months
Part 2: Elimination half-life (t1/2) of Tislelizumab SC
时间窗: Up to approximately 3.5 months
Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to approximately 27 months
Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v5.0\]), timing, seriousness, and relationship to study therapy.
次要结局
- Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC(Up to approximately 2 months)
- Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to approximately 27 months)
- Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies(Up to 25 months)
- Part 2: Overall Response Rate (ORR) of Tislelizumab SC(Up to approximately 27 months)
- Part 2: Duration of Response (DOR) of Tislelizumab SC(Up to approximately 27 months)
- Part 2: Progression-Free Survival (PFS)(Up to approximately 27 months)