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.
- Conditions
- Urothelial CarcinomaRenal Cell CarcinomaMelanomaNon-mucosal Melanoma
- Interventions
- Registration Number
- NCT05661955
- Lead Sponsor
- BeiGene
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 202
- 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)
Key
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Previously Treated UC BGB-A445 BGB-A445 Monotherapy Cohort B: Previously Treated UC BGB-A445 BGB-A445 and Tislelizumab Cohort B: Previously Treated UC Tislelizumab BGB-A445 and Tislelizumab Cohort D: Previously Treated RCC Tislelizumab BGB-A445 and Tislelizumab Cohort E: Previously Treated Melanoma BGB-A445 BGB-A445 Monotherapy Cohort F: Previously Treated Melanoma BGB-A445 BGB-A445 and Tislelizumab Cohort F: Previously Treated Melanoma Tislelizumab BGB-A445 and Tislelizumab Cohort G: First Line Cisplatin Ineligible UC BGB-A445 BGB-A445 and Tislelizumab Cohort G: First Line Cisplatin Ineligible UC Tislelizumab BGB-A445 and Tislelizumab Cohort H: First Line Non-mucosal Melanoma BGB-A445 BGB-A445 and Tislelizumab Cohort H: First Line Non-mucosal Melanoma Tislelizumab BGB-A445 and Tislelizumab Cohort I: Previously Treated Non-mucosal Melanoma Tislelizumab BGB-A445 and Tislelizumab Cohort I: Previously Treated Non-mucosal Melanoma BGB-A445 BGB-A445 and Tislelizumab Cohort C: Previously Treated RCC BGB-A445 BGB-A445 Monotherapy Cohort D: Previously Treated RCC BGB-A445 BGB-A445 and Tislelizumab
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) as Assessed by the Investigator Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
- Secondary Outcome Measures
Name Time Method Disease-Control Rate (DCR) Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1.
Clinical benefit rate (CBR) Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first CBR is defined as the percentage of participants with best overall response of CR, PR, or stable disease lasting for at least 24 weeks as determined from tumor assessments by the investigator using RECIST v1.1.
Number of Participants Experiencing Adverse Events (AEs) Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy Number of participants with AEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed
Number of Participants Experiencing Serious Adverse Events (SAEs) Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy Number of participants with SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed
Trial Locations
- Locations (18)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, 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, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China