Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
NCT ID: NCT03379259
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2017-11-27
2020-09-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1A: BGB-A333 monotherapy dose escalation
BGB-A333
Anti-PD-L1 antibody
Phase 2A: BGB-A333 monotherapy dose expansion
BGB-A333
Anti-PD-L1 antibody
Phase 1B: BGB-A333 and BGB-A317 dose confirmation
BGB-A333
Anti-PD-L1 antibody
BGB-A317
Anti-PD-1 antibodies
Phase 2B: BGB-A333 and BGB-A317 dose expansion
BGB-A333
Anti-PD-L1 antibody
BGB-A317
Anti-PD-1 antibodies
Interventions
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BGB-A333
Anti-PD-L1 antibody
BGB-A317
Anti-PD-1 antibodies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
3. Has adequate organ function
Exclusion Criteria
2. Active autoimmune diseases or history of autoimmune diseases that may relapse.
3. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma)
4. Concurrent participation in another therapeutic clinical trial.
5. Received prior therapies targeting PD-1 or PD-L1.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: PRINCIPAL_INVESTIGATOR
BeiGene
Locations
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Monash Health
Clayton, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Nucleus Network
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Auckland City Hospital
Auckland, , New Zealand
Institut Catala Doncologia
Barcelona, , Spain
Start Madrid Fundacion Jimenez Diaz
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Countries
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References
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Desai J, Fong P, Moreno V, Frentzas S, Meniawy T, Markman B, Voskoboynik M, Rahman T, Budha N, Wu J, Marlow J, Yang S, Calvo E, Martin-Liberal J. A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours. Br J Cancer. 2023 Apr;128(8):1418-1428. doi: 10.1038/s41416-022-02128-3. Epub 2023 Feb 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000265-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BGB-900-101
Identifier Type: -
Identifier Source: org_study_id
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