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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
Sponsor: BeOne Medicines
Summary
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
392
Start Date
2024-07-23
Completion Date
2028-05-30
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
BGB-B2033
Administered by intravenous infusion
Tislelizumab
Administered by intravenous infusion
Bevacizumab
Administered by intravenous infusion
Locations (29)
City of Hope Phoenix Cancer Center
Goodyear, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope Chicago Cancer Center
Zion, Illinois, United States
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
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, 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 Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch
Nanchang, Jiangxi, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
Hopital Beaujon
Clichy, France
Kindai University Hospital
Sakai, Osaka, Japan
Auckland City Hospital
Auckland, New Zealand
Hospital Oncologico
Rio Piedras, Puerto Rico
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea