Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-26808 · 1 trial · 2 indications
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
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.
RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Dose Escalation | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab. |
| Phase 1b: Dose Expansion | EXPERIMENTAL | Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated. |
| Name | Type | Description |
|---|---|---|
| BGB-26808 | DRUG | Planned doses administered orally as a tablet daily. |
| Tislelizumab | DRUG | Planned doses administered by intravenous infusion. |
| Chemotherapy | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information. |
Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. Phase 1a: Participants with histologically or cytologically confirmed adva...
| 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-26808 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently being studied in a Phase 1 clinical trial, both alone and in combination with another drug, in participants with advanced solid tumors or solid tumors.
The specific molecular target of BGB-26808 has not been disclosed in available information. It is a small molecule modality under investigation for oncology indications, but its mechanism of action is not publicly detailed.
BGB-26808 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 research on this investigational drug for advanced solid tumors.
BGB-26808 is currently in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being evaluated for safety and efficacy in patients with advanced solid tumors.
BGB-26808 is being studied in a Phase 1 clinical trial identified as NCT05981703. This trial investigates BGB-26808 alone or in combination with tislelizumab in participants with advanced solid tumors. The study is recruiting participants in the United States, Australia, China, and New Zealand.
No, BGB-26808 is not the same as tislelizumab. BGB-26808 is an investigational small molecule being studied alone or in combination with tislelizumab in a clinical trial for advanced solid tumors. Tislelizumab is a separate drug used in combination with BGB-26808 in this study.