Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-C354 · 1 trial · 1 indication
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively
The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Part A (Monotherapy Dose Escalation) | EXPERIMENTAL | BGB-C354 monotherapy doses at sequentially increasing levels. |
| Phase 1a: Part B (Safety Expansion) | EXPERIMENTAL | Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation. |
| Phase 1b: Part C (Monotherapy Expansion) | EXPERIMENTAL | BGB-C354 will be administered at the recommended dose for expansion (RDFE). |
| Phase 1b: Part D (Combination Therapy Expansion) | EXPERIMENTAL | BGB-C354 and tislelizumab will be adminsitered at doses determined by the SMC. |
| Name | Type | Description |
|---|---|---|
| BGB-C354 | DRUG | Administered by intravenous infusion |
| Tislelizumab | DRUG | Administered by intravenous infusion |
Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Participants with histologically or cytologically confirmed advanced...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BGB-C354 is an investigational therapy being studied for the treatment of advanced solid tumors. It is being developed by BeOne Medicines Ltd. and has been evaluated in a Phase 1 clinical trial. It is not approved for any indication and remains in clinical development.
BGB-C354 targets B7H3, a protein expressed on certain tumor cells. It is an antibody-drug conjugate (ADC) designed to deliver a therapeutic payload to B7H3-expressing cells. This targeted approach aims to focus treatment on tumor tissue while limiting effects on normal cells.
BGB-C354 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is evaluating the agent in a first-in-human study for advanced solid tumors, both as a single agent and in combination with tislelizumab.
BGB-C354 is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency for any indication.
BGB-C354 has been studied in a single Phase 1 trial, NCT06422520, titled a first-in-human study of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. The trial enrolled 63 participants across the United States, Australia, and China and is now completed.