Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06422520 | A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors | PHASE1 | COMPLETED | 63 | — | — | Jul 8, 2024 | May 15, 2026 | Jun 8, 2026 | 14 | United States, Australia +1 |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |