A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors.
Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma
About this trial
This is an interventional treatment trial for Urothelial Carcinoma focused on measuring Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma, advanced solid tumors
Eligibility Criteria
Inclusion Criteria: Participants described in the following cohorts, who have received at least 1 but no more than 3 lines of prior systemic therapy for histologically or cytologically confirmed advanced and/or metastatic UC, RCC or melanoma 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 v1.1. 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) Exclusion Criteria: 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
Sites / Locations
- Peking University First HospitalRecruiting
- Beijing Cancer HospitalRecruiting
- Fujian Cancer HospitalRecruiting
- Lanzhou University Second HospitalRecruiting
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- Sun Yat Sen University Cancer CenterRecruiting
- The Tumor Hospital Affiliated to Guangxi Medical UniversityRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- The Third Peoples Hospital of ZhengzhouRecruiting
- Tongji Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
- The First Hospital of Jilin UniversityRecruiting
- Liaoning Cancer Hospital and InstituteRecruiting
- Shandong Cancer HospitalRecruiting
- Jining No Peoples Hospital Main BranchRecruiting
- Shanxi Provincial Cancer HospitalRecruiting
- West China Hospital, Sichuan UniversityRecruiting
- The Second Affiliated Hospital of Tianjin Medical UniversityRecruiting
- Tianjin Medical University Cancer Institute and HospitalRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Previously Treated UC Cohort A
Previously Treated UC Cohort B
Previously Treated RCC Cohort C
Previously Treated RCC Cohort D
Previously Treated Melanoma Cohort E
Previously Treated Melanoma Cohort F
BGB-A445 Monotherapy
BGB-A445 and Tislelizumab
BGB-A445 Monotherapy
BGB-A445 and Tislelizumab
BGB-A445 Monotherapy
BGB-A445 and Tislelizumab