Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-C0902 · 1 trial · 2 indications
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 BG-C0902 will be determined based upon the MTD or MAD.
RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
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 the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Dose Escalation and Safety Expansion of BG-C0902 | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy. |
| Phase 1b: Dose Expansion of BG-C0902 | EXPERIMENTAL | The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors. |
| Name | Type | Description |
|---|---|---|
| BG-C0902 | DRUG | Administered by intravenous infusion |
Inclusion Criteria: * Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated. * Participants must be able to provide archival tissue formalin-...
| 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-C0902 is an investigational small molecule antibody-drug conjugate being developed for the treatment of solid tumors, including advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BG-C0902 targets EGFR, the epidermal growth factor receptor. As an antibody-drug conjugate, it is designed to deliver a cytotoxic agent to cells expressing EGFR, which is commonly found in certain solid tumors.
BG-C0902 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 safety and efficacy of this investigational drug.
BG-C0902 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety, tolerability, and potential efficacy in patients with advanced solid tumors.
BG-C0902 is being studied in a first-in-human Phase 1 trial (NCT07181681) that is currently recruiting participants. The trial evaluates BG-C0902 alone and in combination with other therapeutic agents in patients with advanced solid tumors, with an enrollment target of 63 participants across the United States, Australia, and China.
BG-C0902 is a distinct investigational antibody-drug conjugate that targets EGFR. While other EGFR-targeting therapies exist, BG-C0902 is a unique small molecule conjugate developed by BeOne Medicines Ltd. and is not the same as any other approved or investigational drug.