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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma; Renal Cell Carcinoma; Urothelial Carcinoma; Non-mucosal Melanoma
• Intervention / Treatment: Drug: Tislelizumab; Drug: BGB-A445

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • The Second Hospital and Clinical Medical School, Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhujiang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat sen University Cancer Center
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital and Institute
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Jining, Shandong, China, 272000
      • Jining No1 Peoples Hospital West Branch
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Provincial Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Previously Treated UC; BGB-A445 Monotherapy	Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort B: Previously Treated UC; BGB-A445 and Tislelizumab	Drug: Tislelizumab; administered intravenously; Other Names: BGB-A317; Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort C: Previously Treated RCC; BGB-A445 Monotherapy	Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort D: Previously Treated RCC; BGB-A445 and Tislelizumab	Drug: Tislelizumab; administered intravenously; Other Names: BGB-A317; Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort E: Previously Treated Melanoma; BGB-A445 Monotherapy	Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort F: Previously Treated Melanoma; BGB-A445 and Tislelizumab	Drug: Tislelizumab; administered intravenously; Other Names: BGB-A317; Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort G: First Line Cisplatin Ineligible UC; BGB-A445 and Tislelizumab	Drug: Tislelizumab; administered intravenously; Other Names: BGB-A317; Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort H: First Line Non-mucosal Melanoma; BGB-A445 and Tislelizumab	Drug: Tislelizumab; administered intravenously; Other Names: BGB-A317; Drug: BGB-A445; administered intravenously; Other Names: Gimistotug
Experimental: Cohort I: Previously Treated Non-mucosal Melanoma; BGB-A445 and Tislelizumab	Drug: Tislelizumab; administered intravenously; Other Names: BGB-A317; Drug: BGB-A445; administered intravenously; Other Names: Gimistotug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Control Rate (DCR)	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.	Up to approximately 26 months
Clinical Benefit Rate (CBR)	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.	Up to approximately 26 months
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with AEs and 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) as needed	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

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): May 27, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Urothelial Carcinoma; Melanoma; Renal Cell Carcinoma; Advanced solid tumors; Non-mucosal melanoma
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Urologic Neoplasms; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Carcinoma, Renal Cell; Melanoma; Carcinoma, Transitional Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; tislelizumab
• Other Study ID Numbers: BGB-A317-A445-201; CTR20223270 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No