Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-C477 · 1 trial · 1 indication
Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Clinical Interest (AECI) 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 BG-C477 monotherapy will be determined based upon available data.
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 per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: BG-C477 Monotherapy Dose Escalation | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy. |
| Phase 1a: BG-C477 Monotherapy Safety Expansion | EXPERIMENTAL | Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy. |
| Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose Optimization | EXPERIMENTAL | Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a. |
| Phase 1b Part B: Combination Therapy Expansion | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with anticancer agents, including chemotherapy or tislelizumab. |
| Name | Type | Description |
|---|---|---|
| BG-C477 | DRUG | Administered intravenously. |
| Tislelizumab | DRUG | Administered intravenously. |
| Chemotherapy | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information. |
Inclusion Criteria: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent * Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy * Phase 1a (Dose Escalation): Histologically confirmed advanced, metastati...
| 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-C477 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a clinical trial that is actively recruiting participants.
BG-C477 targets CEA, a tumor-associated antigen. CEA is a protein that is often overexpressed on the surface of certain cancer cells. By targeting this antigen, BG-C477 is designed to interact with cancer cells that express CEA, which is relevant to its potential use in advanced solid tumors.
BG-C477 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 drug candidate for the treatment of advanced solid tumors.
BG-C477 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies for commercial use. The ongoing Phase 1 trial is designed to evaluate the drug in participants with advanced solid tumors.
BG-C477 is being studied in a Phase 1 clinical trial with the identifier NCT06596473. This trial is titled 'A Study of BG-C477 in Participants With Advanced Solid Tumors' and is currently recruiting participants. The trial is being conducted in multiple countries, including the United States, Australia, China, Japan, Malaysia, New Zealand, South Korea, and Thailand.
BG-C477 is a distinct investigational drug candidate developed by BeOne Medicines Ltd. It is a small molecule that targets CEA, a tumor-associated antigen. No alternative names for BG-C477 have been disclosed in the available information.