Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-C137 · 1 trial · 1 indication
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.
RDFE(s) is determined based on relevant data, as available
The RP2D of BG-C137 monotherapy will be determined based on relevant data, as available
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Monotherapy Dose Escalation and Safety Expansion | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy |
| Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion | EXPERIMENTAL | Sequential cohorts will be evaluated to confirm the safety levels of BG-C137 in combination with other anticancer agents at selected dose levels that have been determined to be safe in Monotherapy Dose Escalation |
| Phase 1b: Dose Expansion | EXPERIMENTAL | Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications |
| Name | Type | Description |
|---|---|---|
| BG-C137 | DRUG | Administered intravenously |
| Anticancer Agents | DRUG | Administered intravenously or orally |
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced or metastatic solid tumors. 2. Life expectancy of ≥ 3 months. 3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not t...
| 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-C137 is an investigational antibody drug conjugate being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BG-C137 targets fibroblast growth factor receptor 2b (FGFR2b). It is an antibody drug conjugate designed to deliver a therapeutic payload to cells expressing FGFR2b, which is being evaluated in patients with advanced solid tumors.
BG-C137 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors.
BG-C137 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants with advanced solid tumors.
BG-C137 is being studied in a first-in-human Phase 1 clinical trial with the identifier NCT06625593. This trial is recruiting 168 participants with advanced solid tumors across the United States, Australia, China, and South Korea.
BG-C137 is an anti-FGFR2b antibody drug conjugate. It is designed to target the FGFR2b protein, which is expressed on certain tumor cells. The drug is being investigated for its potential to treat advanced solid tumors in a Phase 1 clinical trial.