Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-B2033 · 1 trial · 5 indications
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy \[ASTCT\] for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
The MTD or MAD is defined as the highest dose that is tolerable or the highest dose administered, respectively.
The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
| Arm | Type | Description |
|---|---|---|
| Part A (Monotherapy Dose Escalation and Safety Expansion) | EXPERIMENTAL | Ascending dose levels of BGB-B2033 monotherapy |
| Part B (Doublet Run-in) | EXPERIMENTAL | A cohort designed to evaluate the safety and tolerability of BGB-B2033 in combination with tislelizumab and to inform the starting dose of BGB-B2033 for subsequent triplet dose escalation. |
| Part B (Triplet Dose Escalation) | EXPERIMENTAL | Cohorts evaluating BGB-B2033 in combination with tislelizumab and bevacizumab to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDFE) of the combination. |
| Part B (Triplet and Doublet Safety Expansion) | EXPERIMENTAL | Safety expansion arm for each combination therapy cohort (triplet and doublet) |
| Part C (Asia Monotherapy Dose Expansion in HCC) | EXPERIMENTAL | Participants in Asian countries with HCC |
| Part D (US Monotherapy Dose Expansion in HCC) | EXPERIMENTAL | Participants in the United States (US) with HCC |
| Name | Type | Description |
|---|---|---|
| BGB-B2033 | DRUG | Administered by intravenous infusion |
| Tislelizumab | DRUG | Administered by intravenous infusion |
| Bevacizumab | DRUG | Administered by intravenous infusion |
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...
BGB-B2033 is an investigational small molecule being studied for the treatment of metastatic hepatocellular carcinoma. It is currently in Phase 1 clinical development, where it is being evaluated alone or in combination with other therapies in participants with advanced or metastatic solid tumors, including metastatic hepatocellular carcinoma.
BGB-B2033 targets GPC3, a protein that is expressed in certain solid tumors. By targeting GPC3, the drug aims to interfere with tumor growth. This mechanism is being investigated in a Phase 1 clinical trial for conditions such as metastatic hepatocellular carcinoma and other GPC3-positive tumors.
BGB-B2033 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced or metastatic solid tumors.
BGB-B2033 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in various solid tumor indications.
BGB-B2033 is being studied in a Phase 1 clinical trial registered as NCT06427941. This trial evaluates BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in participants with advanced or metastatic solid tumors. The trial is currently recruiting and has an estimated enrollment of 392 participants.
No, BGB-B2033 is a distinct investigational drug that targets GPC3. Tislelizumab and bevacizumab are separate therapies being studied in combination with BGB-B2033 in the clinical trial. The trial is designed to assess the effects of BGB-B2033 when used alone or alongside these other agents.