Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-75098 · 1 trial · 1 indication
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.
MTD is determined based on a target for dose-limiting toxicities. MAD is defined as the maximum administered dose, and it is used when MTD is not reached.
The RDFE(s) will be determined from safety, tolerability, pharmacokinetic, pharmacodynamic biomarker(s), preliminary antitumor activity, and any other relevant data that are obtained from the dose escalation phase.
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy. |
| Phase 1a, Part B: Dose Escalation, BG-75098 Combination | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant. |
| Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination | EXPERIMENTAL | Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant. |
| Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy | EXPERIMENTAL | Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a. |
| Name | Type | Description |
|---|---|---|
| BG-75098 | DRUG | Administered orally. |
| BGB-43395 | DRUG | Administered orally. |
| Fulvestrant | DRUG | Administered by intramuscular injection. |
Inclusion Criteria: * Participants must have measurable disease as assessed by RECIST v1.1. * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have adequate organ function. * Dose Escalation Part A: Participants with histolo...
| 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 |
BG-75098 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied in clinical trials.
BG-75098 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 solid tumors.
BG-75098 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
BG-75098 is being studied in a Phase 1 clinical trial with the identifier NCT07226349. This trial is titled 'A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors' and is currently recruiting participants in the United States, Australia, China, and Denmark.
BG-75098 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by BeOne Medicines Ltd. and is currently in Phase 1 clinical trials for the treatment of advanced solid tumors.