Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-B455 · 1 trial · 2 indications
Number of participants with AEs and SAEs, including laboratory abnormalities, and AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined adverse events of special interest (AESI) 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-B455 will be determined based upon the MTD or MAD.
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR and PR must be confirmed by repeat assessments.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy. |
| Phase 1b: Dose Expansion | EXPERIMENTAL | Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-B455 determined from Phase 1a as monotherapy or in combination with investigator-selected chemotherapy will be evaluated for selected indications based on emerging data. |
| Name | Type | Description |
|---|---|---|
| BGB-B455 | DRUG | Planned doses administered on specified days per protocol. |
| Chemotherapy | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information. |
Inclusion Criteria: * Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high...
| 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-B455 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors. It is currently being studied in a Phase 1 clinical trial in adults with advanced solid tumors or metastatic solid tumors.
BGB-B455 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced or metastatic solid tumors.
BGB-B455 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants with advanced or metastatic solid tumors.
BGB-B455 is being evaluated in a single Phase 1 clinical trial with the identifier NCT06803680. This trial is titled 'A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors' and is currently recruiting participants in the United States, Australia, and China.
The Phase 1 clinical trial of BGB-B455 (NCT06803680) has a planned enrollment of 90 participants. The study is open to adults aged 18 years and older with advanced or metastatic solid tumors, and it is currently recruiting.