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 Patients With Selected Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Phase 1a: Number of Participants Experiencing 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.
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
- •Age 18 or older
- •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)
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
- •Women who are pregnant or are breastfeeding
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Phase 1b: Dose Expansion
BGB-B167 alone or in combination with tislelizumab (BGB-A317)
干预措施: BGB-B167 (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 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 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 Experiencing Serious Adverse Events (SAEs)
时间窗: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to approximately 3 years
Phase 1a: Recommended Phase 2 doses (RP2Ds)
时间窗: Up to 90 days after the last dose of study drug(s); up to approximately 3 years
RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
时间窗: Up to approximately 3 years
Phase 1a: Maximum tolerated dose (MTD)
时间窗: Up to approximately 3 years
MTD is defined as the highest tolerated dose with the target toxicity rate of 30%
Phase 1b: Objective Response Rate (ORR)
时间窗: Up to approximately 3 years
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
次要结局
- Phase 1a and 1b: Duration of Response (DOR)(Up to approximately 3 years)
- Phase 1a and 1b: Disease Control Rate (DCR)(Up to approximately 3 years)
- Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)(Up to approximately 3 years)
- Phase 1a: ORR(Up to approximately 3 years)
- Phase 1a and 1b: Clinical Benefit Rate (CBR)(Up to approximately 3 years)
- Phase 1b: Progression-free Survival (PFS)(Up to approximately 3 years)
- Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Serum Concentration of Tislelizumab(Up to approximately 3 years)
- Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Total body clearance (CL) of BGB-B167(Up to approximately 3 years)
- Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167(Up to approximately 3 years)
- Phase 1b: Number of Participants with AEs or SAEs(Up to approximately 3 years)
- Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167(Up to approximately 3 years)