BGB-B2033 / BeOne Medicines - LARVOL DELTA

Phase 1 study of BGB-B2033 (GPC3 x 4-1BB bispecific antibody) Monotherapy: First Disclosure of Dose Optimization (DO) and Dose Escalation (DE) Update in Advanced Hepatocellular Carcinoma (HCC) (ESMO 2026) - No abstract available

Bispecific • Metastases • Monotherapy • P1 data • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

BGB-B2033-101: A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=630 | Recruiting | Sponsor: BeOne Medicines | Phase classification: P1 ➔ P1/2 | N=392 ➔ 630 | Trial completion date: May 2028 ➔ Oct 2028 | Trial primary completion date: May 2028 ➔ Mar 2027

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Gastric Cancer • Germ Cell Tumors • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AFP • GPC3

A phase 1 study of BGB-B2033 (GPC3 x 4-1BB bispecific antibody) monotherapy in patients with selected advanced or metastatic solid tumors: First disclosure of clinical data. (ASCO 2026) - P1 | "BGB-B2033 was generally well tolerated, with limited imAEs in this predominantly 2L+ HCC population. Durable responses were observed in pts with advanced HCC, including pts with prior PD-(L)1-based treatment. Triplet dose escalation with tislelizumab and bevacizumab as well as monotherapy dose expansion are ongoing."

Bispecific • Clinical data • First-in-human • Metastases • Monotherapy • P1 data • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GPC3

BGB-B2033: Initiation of Part B of P1 trial (NCT06427941) for advanced or metatstatic solid tumors in H2 2027 (BeOne Medicines) - ASCO 2026

Trial initiation date • Oncology • Solid Tumor

…Oral presentations at ASCO highlight rapid acceleration of BeOne’s solid tumor pipeline (Businesswire) - "Key data presentations across our solid tumor programs include: (i) First disclosure of anti-tumor effects and safety/tolerability profile of the highly selective CDK4 inhibitor BGB-43395 Phase 1 treatment data in first-line HR-positive/HER2-negative breast cancer; (ii) Rapid oral presentation on BG-C9074, a promising B7-H4-targeting ADC, with Phase 1 dose escalation and safety expansion data; (iii) Rapid oral presentation on BGB-B2033, a potentially first-in-class GPC3 x 4-1BB bispecific antibody, with first clinical data of a Phase 1 study in heavily pre-treated hepatocellular carcinoma patients."

P1 data • Hepatocellular Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

First Quarter 2026 Business Highlights (Businesswire) - "Gastrointestinal Cancers - BGB-B2033 (GPC3x41BB bispecific antibody): Initiated potentially registrational study in patients with HCC. Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO. Lung Cancer - BG-C0979 (ADAM9-targeting ADC): Initiated first-in-human study."

First-in-human • P1 data • Trial status • Hepatocellular Cancer • Solid Tumor

BGB-B2033-101: 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 (clinicaltrials.gov) - P1 | N=392 | Recruiting | Sponsor: BeOne Medicines | N=140 ➔ 392 | Trial completion date: Dec 2026 ➔ May 2028 | Trial primary completion date: Oct 2026 ➔ May 2028

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Gastric Cancer • Germ Cell Tumors • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AFP • GPC3

BGB-B2033-101: 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 (clinicaltrialsregister.eu) - P1 | N=56 | Not yet recruiting | Sponsor: BeOne Medicines AG

New P1 trial • Oncology • Solid Tumor

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)."

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

BeOne Medicine (ONC) has received orphan drug designation from the U.S. FDA for its experimental treatment, BGB-B2033, aimed at hepatocellular carcinoma, the most prevalent form of liver cancer. (Gurufocus) - "This investigational therapy, currently in phase 1 trials, is a bispecific antibody designed to target GPC3 and 4-1BB. BeOne Medicine suggests that the efficacy of BGB-B2033 could be further enhanced when combined with Tevimbra (tislelizumab), another of its monoclonal antibody products."

Orphan drug • Hepatocellular Cancer

Anticipated R&D Milestones (Businesswire) - "BGB-43395 (CDK4 inhibitor): Phase 3 trial initiation for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer: 1H 2026...BGB-B2033 (GPC3x41BB bispecific antibody): Potentially registrational Phase 2 trial initiation: 2H 2026."

New P2 trial • New P3 trial • Gastrointestinal Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

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

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