RecruitingRecruiting
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
NCT06427941 · BeOne Medicines
In plain English
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Official title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors
About this study
This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors/non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).
Eligibility criteria
Key Inclusion Criteria:
1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types:
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.
Key Exclusion Criteria:
1. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137).
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.
Note: Additional protocol-defined inclusion and exclusion criteria may apply.
Study design
Enrollment target: 392 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-23
Estimated completion: 2028-05-30
Last updated: 2026-06-03
Interventions
Drug: BGB-B2033Drug: TislelizumabDrug: Bevacizumab
Primary outcomes
- • Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to approximately 2 years)
- • Part A and B: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033 (Up to approximately 2 years)
- • Part A and B: Recommended Phase 2 dose (RP2D) of BGB-B2033 (Up to approximately 2 years)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 1.877.828.5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (46)
City of Hope Phoenix Cancer CenterRecruiting
Goodyear, Arizona, United States
City of Hope National Medical CenterRecruiting
Duarte, California, United States
City of Hope Chicago Cancer CenterRecruiting
Zion, Illinois, United States
Memorial Sloan Kettering Cancer Center MskccRecruiting
New York, New York, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)Recruiting
Pittsburgh, Pennsylvania, United States
Scri Oncology PartnersRecruiting
Nashville, Tennessee, United States
The University of Texas Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Centro Gaucho Integrado de Oncologia Hospital Mae de DeusRecruiting
Porto Alegre, Brazil
Hospital Da BahiaRecruiting
Salvador, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio PretoRecruiting
São José do Rio Preto, Brazil
Anhui Provincial HospitalRecruiting
Hefei, Anhui, China
Chongqing University Cancer HospitalRecruiting
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical UniversityRecruiting
Fuzhou, Fujian, China
Zhujiang Hospital of Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital Wuxiang BranchRecruiting
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical UniversityRecruiting
Shijiazhuang, Hebei, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Hunan Cancer HospitalRecruiting
Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang Universityhongjiaozhou BranchRecruiting
Nanchang, Jiangxi, China
Sichuan Cancer Hospital and InstituteRecruiting
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China
Lishui Central HospitalRecruiting
Lishui, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, Zhejiang, China
Hopital BeaujonRecruiting
Clichy, France
Centre Hospitalier Universitaire Nantes Hotel DieuRecruiting
Nantes, France
Institut Gustave RoussyRecruiting
Villejuif, France
Irccs Istituto Nazionale Tumori Fondazione PascaleRecruiting
Naples, Italy
Fondazione Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
Irccs Humanitas Research HospitalRecruiting
Rozzano, Italy
Kindai University HospitalRecruiting
Sakai, Osaka, Japan
Tokyo Metropolitan Komagome HospitalRecruiting
Bunkyoku, Tokyo, Japan
Cancer Institute Hospital of JfcrRecruiting
Kotoku, Tokyo, Japan
Auckland City HospitalRecruiting
Auckland, New Zealand
Hospital OncologicoRecruiting
Rio Piedras, Puerto Rico
Chungbuk National University HospitalRecruiting
Cheongju-si, Chungcheongbukdo, South Korea
Cha Bundang Medical Center, Cha UniversityRecruiting
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical CenterRecruiting
GangnamGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical CenterRecruiting
SongpaGu, Seoul Teugbyeolsi, South Korea