Phase 1b/2 Study Investigating the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of the Anti-OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced or Metastatic Urothelial Carcinoma, Renal Cell Carcinoma, or Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 113
- 试验地点
- 33
- 主要终点
- Overall Response Rate (ORR) as Assessed by the Investigator
研究概览
简要总结
The objective of this study is to assess the overall response rate, evaluate the antitumor activity, and characterize the safety and tolerability of BGB-A445 alone or in combination with tislelizumab in participants With Advanced or Metastatic Urothelial Carcinoma (UC), Renal Cell Carcinoma (RCC), or Melanoma
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 who were histologically or cytologically confirmed advanced and/or metastatic cancer. UC participants (Cohort A and B), RCC patients (Cohort C and D) or melanoma participants (Cohort E and F) who have received at least 1 but no more than 3 lines of prior systemic therapy. Cisplatin ineligible UC participants (Cohort G) who have received no prior systemic therapy and have PD-L1 CPS ≥
- •Melanoma patients (Cohort H) with non-mucosal melanoma who have no previous systemic treatment. Melanoma participants (Cohort I) with non-mucosal melanoma who were CPI pretreated and have 1 or 2 lines of prior systemic therapy. Participants must not have received prior therapy targeting OX40 or any other T-cell agonists.
- •Has at least 1 measurable lesion as defined per RECIST v1.
- •Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample
- •ECOG PS ≤ 1 (Participants with UC could have an ECOG PS ≤ 2) and a life expectancy of≥ 3 months
- •Adequate organ function as indicated by the laboratory values up to the first dose of study drug(s)
排除标准
- •Active leptomeningeal disease or uncontrolled brain metastasis
- •Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy
- •Any active malignancy ≤ 2 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
- •Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions:
- •Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
- •Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
- •Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
- •With uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia occurring ≤ 14 days before the first dose of study drug(s)
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Cohort B: Previously Treated UC
BGB-A445 and Tislelizumab
干预措施: BGB-A445 (Drug)
Cohort F: Previously Treated Melanoma
BGB-A445 and Tislelizumab
干预措施: Tislelizumab (Drug)
Cohort I: Previously Treated Non-mucosal Melanoma
BGB-A445 and Tislelizumab
干预措施: Tislelizumab (Drug)
Cohort A: Previously Treated UC
BGB-A445 Monotherapy
干预措施: BGB-A445 (Drug)
Cohort D: Previously Treated RCC
BGB-A445 and Tislelizumab
干预措施: BGB-A445 (Drug)
Cohort D: Previously Treated RCC
BGB-A445 and Tislelizumab
干预措施: Tislelizumab (Drug)
Cohort C: Previously Treated RCC
BGB-A445 Monotherapy
干预措施: BGB-A445 (Drug)
Cohort F: Previously Treated Melanoma
BGB-A445 and Tislelizumab
干预措施: BGB-A445 (Drug)
Cohort E: Previously Treated Melanoma
BGB-A445 Monotherapy
干预措施: BGB-A445 (Drug)
Cohort I: Previously Treated Non-mucosal Melanoma
BGB-A445 and Tislelizumab
干预措施: BGB-A445 (Drug)
Cohort H: First Line Non-mucosal Melanoma
BGB-A445 and Tislelizumab
干预措施: BGB-A445 (Drug)
Cohort G: First Line Cisplatin Ineligible UC
BGB-A445 and Tislelizumab
干预措施: BGB-A445 (Drug)
Cohort B: Previously Treated UC
BGB-A445 and Tislelizumab
干预措施: Tislelizumab (Drug)
Cohort G: First Line Cisplatin Ineligible UC
BGB-A445 and Tislelizumab
干预措施: Tislelizumab (Drug)
Cohort H: First Line Non-mucosal Melanoma
BGB-A445 and Tislelizumab
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) as Assessed by the Investigator
时间窗: Up to approximately 26 months
ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
Overall Response Rate (ORR) as Assessed by the Investigator
时间窗: Up to approximately 26 months
ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
次要结局
- Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 30 days after the last dose of study drugs or the initiation of new anticancer therapy, whichever comes earlier, up to 22 months)
- Disease-Control Rate (DCR)(Up to approximately 26 months)
- Clinical Benefit Rate (CBR)(Up to approximately 26 months)
- Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 30 days after the last dose of study drugs or the initiation of new anticancer therapy, whichever comes earlier, up to 22 months)