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.

Last updated: May 8, 2026
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Cancer/tumors

Kidney Cancer

Melanoma

Treatment

Tislelizumab

BGB-A445

Clinical Study ID

NCT05661955
BGB-A317-A445-201
CTR20223270
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Key Inclusion Criteria:

  1. Participants who were histologically or cytologically confirmed advanced and/ormetastatic 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 morethan 3 lines of prior systemic therapy. Cisplatin ineligible UC participants (CohortG) who have received no prior systemic therapy and have PD-L1 CPS ≥ 10. Melanomapatients (Cohort H) with non-mucosal melanoma who have no previous systemictreatment. Melanoma participants (Cohort I) with non-mucosal melanoma who were CPIpretreated and have 1 or 2 lines of prior systemic therapy. Participants must nothave 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 expectancyof≥ 3 months

  5. Adequate organ function as indicated by the laboratory values up to the first doseof study drug(s)

Exclusion

Key Exclusion Criteria:

  1. Active leptomeningeal disease or uncontrolled brain metastasis

  2. Active autoimmune diseases or history of autoimmune diseases that may relapse orhistory of life-threatening toxicity related to prior immune therapy

  3. Any active malignancy ≤ 2 years before the first dose of study drug(s) except forthe specific cancer under investigation in this study and any locally recurringcancer that has been treated with curative intent

  4. Any condition that required systemic treatment with either corticosteroids (> 10 mgdaily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 daysbefore the first dose of study drug(s), with the following exceptions:

  5. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)

  6. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroidwith minimal systemic absorption

  7. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, forcontrast dye allergy) or for the treatment of a nonautoimmune condition (eg,delayed-type hypersensitivity reaction caused by contact allergen)

  8. With uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium,sodium, or corrected calcium despite standard medical management, or ≥ Grade 3hypoalbuminemia occurring ≤ 14 days before the first dose of study drug(s)

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 113
Treatment Group(s): 2
Primary Treatment: Tislelizumab
Phase: 1/2
Study Start date:
January 09, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Active - Recruiting

  • The Second Hospital and Clinical Medical School, Lanzhou University

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • The Second Hospital and Clinical Medical School, Lanzhou University

    Lanzhou 1804430, Gansu 1810676 730030
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning 1799869, Guangxi 1809867 530021
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • The Third Peoples Hospital of Zhengzhou

    Zhengzhou, Henan 450099
    China

    Completed

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410011
    China

    Site Not Available

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning 110042
    China

    Site Not Available

  • Liaoning Cancer Hospital and Institute

    Shenyang 2034937, Liaoning 2036115 110042
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Jining No Peoples Hospital Main Branch

    Jining, Shandong 272002
    China

    Active - Recruiting

  • Jining No Peoples Hospital West Branch

    Jining, Shandong 272000
    China

    Site Not Available

  • Jining No1 Peoples Hospital West Branch

    Jining, Shandong 272000
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328 250117
    China

    Site Not Available

  • Jining No Peoples Hospital West Branch

    Jining 1805518, Shandong 1796328 272000
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan 1793511, Shanxi 1795912 030013
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • The Second Affiliated Hospital of Tianjin Medical University

    Tianjin, Tianjin 300000
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality 300060
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300060
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764 325000
    China

    Site Not Available

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