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.
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
1. 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 ≥ 10. 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.
2. Has at least 1 measurable lesion as defined per RECIST v1.1.
3. Participants must be able to provide an archived formalin-fixed paraffin embedded (FFPE) tumor tissue sample
4. ECOG PS ≤ 1 (Participants with UC could have an ECOG PS ≤ 2) and a life expectancy of≥ 3 months
5. Adequate organ function as indicated by the laboratory values up to the first dose of study drug(s)
Key Exclusion Criteria:
1. Active leptomeningeal disease or uncontrolled brain metastasis
2. Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy
3. 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
4. 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:
1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
3. 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)
5. 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
Primary outcome measure(s)
Overall Response Rate (ORR) as Assessed by the Investigator — 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)
Trial sites (18)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
Beijing Municipality
Fujian Cancer Hospital
Fuzhou
Fujian
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou
Gansu
Zhujiang Hospital of Southern Medical University
Guangzhou
Guangdong
Sun Yat Sen University Cancer Center
Guangzhou
Guangdong
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan
Hubei
The Second Xiangya Hospital of Central South University
Changsha
Hunan
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing
Jiangsu
The First Hospital of Jilin University
Changchun
Jilin
Liaoning Cancer Hospital and Institute
Shenyang
Liaoning
Shandong Cancer Hospital
Jinan
Shandong
Jining No1 Peoples Hospital West Branch
Jining
Shandong
Shanxi Provincial Cancer Hospital
Taiyuan
Shanxi
West China Hospital, Sichuan University
Chengdu
Sichuan
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
The First Affiliated Hospital of Wenzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.