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Urothelial CarcinomaPhase 1/2NCT05661955

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.

A Phase 1/2 study testing BGB-A445 and Tislelizumab in people with Urothelial Carcinoma and Renal Cell Carcinoma, run by BeiGene at 18 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGB-A445 and Tislelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
18 sitesChina
Study dates
9 Jan 2023to Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jining No1 Peoples Hospital West Branch

    Jining, Shandong, 272000

  • The Second Hospital and Clinical Medical School, Lanzhou University

    Lanzhou, Gansu, 730030

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

    Nanjing, Jiangsu, 210008

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

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

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: 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

Being tested
BGB-A445, Tislelizumab
Keywords
Urothelial Carcinoma, Renal Cell Carcinoma, Melanoma, Advanced solid tumors, Non-mucosal melanoma
Medical subject headings
Carcinoma, Transitional Cell, Carcinoma, Renal Cell, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-A445Drug

    Also called Gimistotug

    administered intravenously

  • TislelizumabDrug

    Also called BGB-A317

    administered intravenously

Study groups in NCT05661955
Study groupRoleWhat they receive
Cohort A: Previously Treated UCExperimentalBGB-A445 Monotherapy
Receives: Drug: BGB-A445
Cohort B: Previously Treated UCExperimentalBGB-A445 and Tislelizumab
Receives: Drug: BGB-A445; Drug: Tislelizumab
Cohort C: Previously Treated RCCExperimentalBGB-A445 Monotherapy
Receives: Drug: BGB-A445
Cohort D: Previously Treated RCCExperimentalBGB-A445 and Tislelizumab
Receives: Drug: BGB-A445; Drug: Tislelizumab
Cohort E: Previously Treated MelanomaExperimentalBGB-A445 Monotherapy
Receives: Drug: BGB-A445
Cohort F: Previously Treated MelanomaExperimentalBGB-A445 and Tislelizumab
Receives: Drug: BGB-A445; Drug: Tislelizumab
Cohort G: First Line Cisplatin Ineligible UCExperimentalBGB-A445 and Tislelizumab
Receives: Drug: BGB-A445; Drug: Tislelizumab
Cohort H: First Line Non-mucosal MelanomaExperimentalBGB-A445 and Tislelizumab
Receives: Drug: BGB-A445; Drug: Tislelizumab
Cohort I: Previously Treated Non-mucosal MelanomaExperimentalBGB-A445 and Tislelizumab
Receives: Drug: BGB-A445; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to approximately 26 months

Secondary outcomes (3)

  1. 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.

    Measured: Up to approximately 26 months

  2. 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.

    Measured: Up to approximately 26 months

  3. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study start9 Jan 2023
  3. Primary completion27 May 2025
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05661955
Sponsor's protocol ID
BGB-A317-A445-201
Other IDs
CTR20223270
Status last verified
May 2026
First submitted
15 Dec 2022
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BGB-A445 and Tislelizumab in people with Urothelial Carcinoma and Renal Cell Carcinoma, run by BeiGene at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) as Assessed by the Investigator (time frame: Up to approximately 26 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05661955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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