A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Chinese Patients With Selected Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid tumors in Chinese participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- •Adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s)
- •Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study
- •Nonsterile men must be willing to use highly effective method of birth control for the duration of the study
排除标准
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- •Active autoimmune diseases or history of autoimmune diseases that may relapse
- •Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
- •History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients
- •Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers
- •Known history of HIV infection.
研究组 & 干预措施
Phase 1a: Dose Escalation
Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)
干预措施: Tislelizumab (Drug)
Phase 1a: Dose Escalation
Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)
干预措施: BGB-B167 (Drug)
Phase 1b: Dose Expansion
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
干预措施: BGB-B167 (Drug)
Phase 1b: Dose Expansion
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to Approximately 30 months
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
时间窗: Up to Approximately 24 months
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-B167
时间窗: Approximately 30 months
The maximum tolerated dose (MTD) is defined as the highest tolerated dose for which the estimated toxicity rate is closest to the target toxicity rate of 30%.
Phase 1a: Recommended Phase 2 doses (RP2Ds)
时间窗: Approximately 24 months
RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose
Phase 1b: Objective Response Rate (ORR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Up to Approximately 30 months
ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR).
次要结局
- Phase 1a: ORR(Up to Approximately 30 months)
- Phase 1a and Phase 1b: Duration of Response (DOR) as determined by investigators per RECIST v1.1.(Up to Approximately 30 months)
- Phase 1a and Phase 1b: Disease Control Rate (DCR) as determined by investigators per RECIST v1.1.(Up to Approximately 30 months)
- Phase 1a and Phase 1b: Clinical Benefit Rate (CBR) as determined by investigators per RECIST v1.1.(Up to Approximately 30 months)
- Phase 1b: Progression Free Survival (PFS) as determined by investigators per RECIST v1.1.(Up to Approximately 30 months)
- Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of BGB-B167(Up to Approximately 30 months)
- Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-B167(Up to Approximately 30 months)
- Phase 1a and Phase 1b: Time to Cmax (Tmax) of BGB-B167(Up to Approximately 30 months)
- Phase 1a: Terminal half-life (t1/2) of BGB-B167(Up to Approximately 30 months)
- Phase 1a: Area Under the Plasma Concentration-time curve (AUC0-7d) of BGB-B167(Up to Approximately 30 months)
- Phase 1a: Clearance (CL) BGB-B167(Up to Approximately 30 months)
- Phase 1a: Volume of Distribution at Steady State (Vss) of BGB-B167(Up to Approximately 30 months)
- Phase 1a and Phase 1b: Number of Participants with Anti-Drug Antibodies (ADAs)(Up to Approximately 30 months)
- Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Approximately 30 months)