A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
NCT ID: NCT06540066
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
75 participants
INTERVENTIONAL
2024-08-30
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Part A: Dose Escalation (BGB-B3227 Monotherapy)
Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated as monotherapy.
BGB-B3227
Administered intravenously.
Phase 1a Part B: Dose Escalation (BGB-B3227 + tislelizumab)
Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated in combination with tislelizumab.
BGB-B3227
Administered intravenously.
Tislelizumab
Administered intravenously.
Phase 1b: Dose Expansion
Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated in combination with tislelizumab and chemotherapy.
BGB-B3227
Administered intravenously.
Tislelizumab
Administered intravenously.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Interventions
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BGB-B3227
Administered intravenously.
Tislelizumab
Administered intravenously.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 measurable lesion per RECIST v1.1
* Stable Eastern Cooperative Oncology Group Performance Status of ≤ 1
* Adequate organ function
* Willing to use a highly effective method of birth control
Exclusion Criteria
* History of severe Infusion-Related Reactions (IRRs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments
* Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic COVID-19 infection
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Active autoimmune disease or history of autoimmune disease(s) that may relapse
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: STUDY_DIRECTOR
BeiGene
Locations
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Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
Washington University in St Louis
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Next Oncology
Austin, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Countries
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Central Contacts
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Other Identifiers
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BGB-B3227-101
Identifier Type: -
Identifier Source: org_study_id
2024-514216-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
CTR20244018
Identifier Type: REGISTRY
Identifier Source: secondary_id
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