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
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 immunohistoch…
Interventions
- DrugBGB-B2033
Administered by intravenous infusion
- DrugTislelizumab
Administered by intravenous infusion
- DrugBevacizumab
Administered by intravenous infusion
Locations (20)
- Memorial Sloan Kettering Cancer Center MskccNew York, New York
- Upmc Hillman Cancer Center(Univ of Pittsburgh)Pittsburgh, Pennsylvania
- Scri Oncology PartnersNashville, Tennessee
- Anhui Provincial HospitalHefei, Anhui
- Mengchao Hepatobiliary Hospital of Fujian Medical UniversityFuzhou, Fujian
- Nanfang Hospital of Southern Medical UniversityGuangzhou, Guangdong