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Clinical Trials in China / NCT05661955
Active, not recruiting Phase 1/2

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.

NCT05661955 · tracked via the Priya Life Science China tracker
Sponsor
BeiGene
Phase
Phase 1/2
Started
2023-01-09
Last updated
2026-05-11

Condition(s) studied

Urothelial CarcinomaRenal Cell CarcinomaMelanomaNon-mucosal Melanoma

Investigational drug(s) / intervention(s)

BGB-A445Tislelizumab

BGB-A445: administered intravenously

Tislelizumab: administered intravenously

Study summary

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)

Trial sites (18)

FacilityCityRegionStatus
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 Wenzhou Zhejiang

More BeiGene trials in China

Other trials for the same condition

Official registry record

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.

View NCT05661955 on ClinicalTrials.gov ↗ ← All trials in China