Fact CheckerSign in

NCT05661955Active, not recruitingPhase 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.

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

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
113 (actual)
First submitted
15 Dec 2022
Start date
9 Jan 2023
Primary completion date
27 May 2025
Lead sponsor
BeiGene
NCT number
NCT05661955

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 113
  • From 9 Jan 2023 to the primary completion date, 27 May 2025
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • Active leptomeningeal disease or uncontrolled brain metastasis

Lab values

  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
The Second Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Zhujiang Hospital of Southern Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Shandong Cancer Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Jining No1 Peoples Hospital West Branch
Coordinator of this site? Confirm its status
JiningChinaUnknown status
The Second Hospital and Clinical Medical School, Lanzhou University
Coordinator of this site? Confirm its status
LanzhouChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Guangxi Medical University Cancer Hospital
Coordinator of this site? Confirm its status
NanningChinaUnknown status
Liaoning Cancer Hospital and Institute
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
Shanxi Provincial Cancer Hospital
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.