Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BGB-58067 Tablet (F-01 Formulation)
BGB-58067 · 2 trials · 2 indications
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached. Note: BGB-58067 + BG-89894 combination has been discontinued.
RDFE of BGB-58067 alone, in combination with BG-89894, and in combination with standard of care therapy will be determined based upon the MTD or MAD. Note: BGB-58067 + BG-89894 combination has been discontinued.
RP2D established from Phase 1a for BGB-58067 alone and in combination with standard of care therapy for administration in selected tumor types.
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), as assessed by the investigator.
Decrease in SDMA expression in tumor tissue collected during Phase 0 surgery relative to baseline will be used if pre-treatment biopsy tissue is available. Otherwise, H-score ≤ 70 in tumor tissue collected during Phase 0 surgery will be used.
Overall survival at 12 months (OS12)
| Arm | Type | Description |
|---|---|---|
| Phase 1a: BGB-58067 Monotherapy Dose Escalation and Safety Expansion | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-58067 as monotherapy will be evaluated. |
| Phase 1a: BGB-58067 + BG-89894 Combination Therapy Dose Escalation | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-58067 in combination with BG-89894 will be evaluated. Enrollment in this combination has been discontinued. |
| Phase 1a: BGB-58067 + Standard of Care Combination Therapy Dose Escalation | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-58067 in combination with standard of care therapy will be evaluated. |
| Phase 1b: Dose Expansion and Optimization | EXPERIMENTAL | Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-58067 alone and in combination with standard of care therapy will be evaluated for selected indications and regimen(s) based on emerging data. |
| Arm A: Unmethylated-MGMT GBM-BGB-58067 Monotherapy | EXPERIMENTAL | Participants with unmethylated-MGMT and MTAP-deleted GBM demonstrating a positive PD response after Phase 0 surgery. |
| Arm B: Methylated-MGMT GBM-BGB-58067 + TMZ Concurrent Therapy | EXPERIMENTAL | Participants with methylated-MGMT and MTAP-deleted GBM demonstrating a positive PD response after Phase 0 surgery. |
| Name | Type | Description |
|---|---|---|
| BGB-58067 | DRUG | Planned doses administered on specified days per protocol. |
| BG-89894 | DRUG | Planned doses administered on specified days per protocol. |
| Standard of Care Therapy | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information. |
Inclusion Criteria: * Participants must sign the ICF and be capable of giving written informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70 * Life expectancy ≥ 3 months * Evidence of homozygous loss of MTAP or lost MTAP e...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BGB-58067 is an investigational small molecule developed by BeOne Medicines Ltd. (ticker ONC) for advanced solid tumors and glioblastoma. It is a PRMT5-targeted agent given as a tablet, including the F-01 formulation, and is currently in Phase 1 clinical development. It has not been approved by any regulatory agency.
BGB-58067 is being studied in adults with advanced solid tumors and in newly diagnosed glioblastoma (GBM). The glioblastoma study enrolls patients whose tumors are MTAP-deleted, and the broader solid tumor study evaluates the drug as a single agent and in combination with anticancer agents.
BGB-58067 targets PRMT5, a protein arginine methyltransferase. PRMT5 is a protein target involved in methylation of arginine residues, and the program is biomarker-selected, with the glioblastoma trial restricted to patients with MTAP-deleted tumors, a setting associated with PRMT5 inhibitor sensitivity.
BGB-58067 is developed by BeOne Medicines Ltd., which trades under the ticker ONC. BeOne is running the clinical program, including a Phase 1 study in advanced solid tumors across the United States, Australia, Brazil, China, Denmark, France, Malaysia, Moldova, South Korea, Spain and Thailand.
BGB-58067 is in Phase 1 development. It is investigational and has not been approved for any indication. The program includes a Phase 1 study in advanced solid tumors and an early-phase study in newly diagnosed glioblastoma, and no trials have been completed to date.
BGB-58067 is being evaluated in NCT06589596, a Phase 1 study of the drug as a single agent and in combination with anticancer agents in advanced solid tumors, which is recruiting with planned enrollment of 525 participants. A second study, NCT07485049, is an early-phase PD-trigger trial in newly diagnosed glioblastoma with MTAP-deleted tumors and is not yet recruiting.
Yes. BGB-58067 Tablet (F-01 Formulation) refers to the same investigational agent as BGB-58067, an oral small molecule PRMT5 inhibitor from BeOne Medicines Ltd. The F-01 designation describes the tablet formulation used in the clinical program rather than a separate drug asset.