BGB-B2033 / BeOne Medicines - LARVOL DELTA

BeOne Medicines Ltd…announced that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track Designation for BGB-B2033, its GPC3x4-1BB bispecific antibody for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment. (The AI Journal) - "BeOne is currently conducting a global, multi-center Phase 1 clinical trial (NCT06427941) to explore the safety and anti-tumor activity of BGB-B2033, both alone and in combination with PD-1 inhibitor TEVIMBRA (tislelizumab)."

Fast track • Hepatocellular Cancer

BGB-B2033, a novel 4-1BB/GPC3 bispecific antibody, exhibits potent in vitro and vivo antitumor activity in preclinical models (AACR 2025) - P1 | "In humanized 4-1BB knock-in mice bearing human GPC3-expressing tumors, BGB-B2033 exhibited potent, dose-associated single-agent efficacy in Hepa1-6/hGPC3 orthotopic tumor model, as well as synergistic antitumor activity in combination with antiPD-1 antibody.In conclusion, BGB-B2033 is a potent therapeutic agent with strong anti-tumor activity in both in vitro and in vivo studies. The phase 1 study of BGB-B2033, alone or in combination with Tislelizumab is ongoing (NCT06427941)."

Preclinical • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3 • TNFRSF9

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: BeiGene

New P1 trial • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor