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.
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
2 other identifiers
interventional
113
1 country
18
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedStudy Start
First participant enrolled
January 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedMarch 20, 2026
March 1, 2026
2.4 years
December 15, 2022
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR) as Assessed by the Investigator
ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
Up to approximately 26 months
Secondary Outcomes (3)
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
Study Arms (9)
Cohort A: Previously Treated UC
EXPERIMENTALBGB-A445 Monotherapy
Cohort B: Previously Treated UC
EXPERIMENTALBGB-A445 and Tislelizumab
Cohort C: Previously Treated RCC
EXPERIMENTALBGB-A445 Monotherapy
Cohort D: Previously Treated RCC
EXPERIMENTALBGB-A445 and Tislelizumab
Cohort E: Previously Treated Melanoma
EXPERIMENTALBGB-A445 Monotherapy
Cohort F: Previously Treated Melanoma
EXPERIMENTALBGB-A445 and Tislelizumab
Cohort G: First Line Cisplatin Ineligible UC
EXPERIMENTALBGB-A445 and Tislelizumab
Cohort H: First Line Non-mucosal Melanoma
EXPERIMENTALBGB-A445 and Tislelizumab
Cohort I: Previously Treated Non-mucosal Melanoma
EXPERIMENTALBGB-A445 and Tislelizumab
Interventions
administered intravenously
administered intravenously
Eligibility Criteria
You may qualify if:
- 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.
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (18)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The Second Hospital and Clinical Medical School, Lanzhou University
Lanzhou, Gansu, 730030, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2022
First Posted
December 22, 2022
Study Start
January 9, 2023
Primary Completion
May 27, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.