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 | 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 |
BGB-C354 is an investigational small molecule 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. The drug is being evaluated as a monotherapy and in combination with tislelizumab in patients with advanced solid tumors.
BGB-C354 is being developed by BeOne Medicines Ltd., a biopharmaceutical company traded 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.
BGB-C354 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial is a first-in-human study designed to evaluate the drug's safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
BGB-C354 is being studied in a Phase 1 clinical trial registered as NCT06422520. This first-in-human study evaluates BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. The trial enrolled 63 participants and has been completed. It was conducted in the United States, Australia, and China.
No, BGB-C354 is not the same as tislelizumab. BGB-C354 is a small molecule being studied as a monotherapy and in combination with tislelizumab in a Phase 1 clinical trial for advanced solid tumors. Tislelizumab is a separate investigational drug used in combination with BGB-C354 in this study.