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.
NCT ID: NCT05661955
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
113 participants
INTERVENTIONAL
2023-01-09
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Previously Treated UC
BGB-A445 Monotherapy
BGB-A445
administered intravenously
Cohort B: Previously Treated UC
BGB-A445 and Tislelizumab
BGB-A445
administered intravenously
Tislelizumab
administered intravenously
Cohort C: Previously Treated RCC
BGB-A445 Monotherapy
BGB-A445
administered intravenously
Cohort D: Previously Treated RCC
BGB-A445 and Tislelizumab
BGB-A445
administered intravenously
Tislelizumab
administered intravenously
Cohort E: Previously Treated Melanoma
BGB-A445 Monotherapy
BGB-A445
administered intravenously
Cohort F: Previously Treated Melanoma
BGB-A445 and Tislelizumab
BGB-A445
administered intravenously
Tislelizumab
administered intravenously
Cohort G: First Line Cisplatin Ineligible UC
BGB-A445 and Tislelizumab
BGB-A445
administered intravenously
Tislelizumab
administered intravenously
Cohort H: First Line Non-mucosal Melanoma
BGB-A445 and Tislelizumab
BGB-A445
administered intravenously
Tislelizumab
administered intravenously
Cohort I: Previously Treated Non-mucosal Melanoma
BGB-A445 and Tislelizumab
BGB-A445
administered intravenously
Tislelizumab
administered intravenously
Interventions
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BGB-A445
administered intravenously
Tislelizumab
administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Jining No Peoples Hospital West Branch
Jining, Shandong, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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CTR20223270
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-A445-201
Identifier Type: -
Identifier Source: org_study_id
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