Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BGB-58067 Tablet (F-01 Formulation)
BGB-58067 · 4 trials · 3 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 |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Participants will receive a single oral dose of BGB-58067 F-01 tablet in fasted state, BGB-58067 F-02 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a high fat meal, and BGB-58067 F-02 tablet in the fed state with a low fat meal, with a 7-day washout between each dose. |
| Treatment Sequence 2 | EXPERIMENTAL | Participants will receive a single oral dose of BGB-58067 F-02 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a low fat meal, BGB-58067 F-01 tablet in fasted state, and BGB-58067 F-02 tablet in the fed state with a high fat meal, with a 7-day washout between each dose. |
| Treatment Sequence 3 | EXPERIMENTAL | Participants will receive a single oral dose of BGB-58067 F-02 tablet in fed state with low-fat meal, F-02 tablet in the fed state with a high fat meal, BGB-58067 F-02 tablet in fasted state, and BGB-58067 F-01 tablet in fasted state, with a 7-day washout between each dose. |
| Treatment Sequence 4 | EXPERIMENTAL | Participants will receive a single oral dose of BGB-58067 F-02 tablet in fed state with high-fat meal, BGB-58067 F-01 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a low fat meal, and BGB-58067 F-02 tablet in fasted state, with a 7-day washout between each dose. |
| Part A: BGB-58067 + Phenytoin (CYP3A Inducer) | EXPERIMENTAL | Participants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20. |
| Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor) | EXPERIMENTAL | Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11. |
| 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 Tablet (F-01 Formulation) | DRUG | Administered orally |
| BGB-58067 Tablet (F-02 Formulation) | DRUG | Administered orally |
| BGB-58067 | DRUG | Administered orally |
| Phenytoin | DRUG | Administered orally |
| Itraconazole | DRUG | Administered orally |
| 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 be 18 to 65 years of age, inclusive, at the time of signing the ICF. * Participants who are overtly healthy, as determined by the investigator or delegate through medical evaluation * Female participants must be of non-childbearing potential. Note: A woman is...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BGB-58067 is an investigational small molecule being studied for advanced solid tumors, glioblastoma (GBM), and in healthy volunteers for pharmacokinetic studies. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BGB-58067 targets PRMT5, a protein involved in cellular processes relevant to cancer. By inhibiting PRMT5, the drug aims to interfere with tumor cell growth, particularly in cancers with specific genetic alterations such as MTAP-deleted glioblastoma.
BGB-58067 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
BGB-58067 is in Phase 1 clinical development. It is being studied in early-phase trials for advanced solid tumors, glioblastoma, and healthy volunteer pharmacokinetic studies. The drug is investigational and has not received regulatory approval.
BGB-58067 is being evaluated in several trials, including NCT06589596 for advanced solid tumors, NCT07485049 for glioblastoma with MTAP-deleted tumors, and NCT07590102 and NCT07712640 for healthy volunteer pharmacokinetic studies. All trials are in Phase 1.
Yes, BGB-58067 Tablet (F-01 Formulation) is an alternative name for BGB-58067. The F-01 formulation refers to a specific tablet version being tested in bioavailability studies, while the drug itself is the same active pharmaceutical ingredient.