A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
NCT ID: NCT06427941
Last Updated: 2026-01-12
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
140 participants
INTERVENTIONAL
2024-07-23
2026-12-31
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
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A (Monotherapy Dose Escalation and Safety Expansion)
Ascending dose levels of BGB-B2033 monotherapy
BGB-B2033
Administered by intravenous infusion
Part B (Combination Dose Escalation and Safety Expansion)
Cohorts of BGB-B2033 in combination with tislelizumab
BGB-B2033
Administered by intravenous infusion
Tislelizumab
Administered by intravenous infusion
Bevacizumab
Administered by intravenous infusion
Interventions
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BGB-B2033
Administered by intravenous infusion
Tislelizumab
Administered by intravenous infusion
Bevacizumab
Administered by intravenous infusion
Eligibility Criteria
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Inclusion Criteria
1. Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach.
2. Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP \> 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing.
3. Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist.
4. Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI).
2. At least one evaluable lesion for dose escalation, and
3. At least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
5. Adequate organ function as defined in the protocol.
6. Provision of tumor tissue samples is required for specified parts of the study.
Exclusion Criteria
2. Active leptomeningeal disease or uncontrolled/untreated brain metastases.
3. Active autoimmune disease or a history of autoimmune disease with potential for relapse.
4. Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent.
5. Requirement for systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s).
6. Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol.
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States
Scri Oncology Partners
Nashville, Tennessee, United States
Anhui Provincial Hospital
Hefei, Anhui, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch
Nanchang, Jiangxi, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Auckland City Hospital
Auckland, , New Zealand
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Countries
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Central Contacts
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Other Identifiers
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2025-524136-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-B2033-101
Identifier Type: -
Identifier Source: org_study_id
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