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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06427941 | A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 392 | — | — | Jul 23, 2024 | May 30, 2028 | Jun 3, 2026 | 46 | United States, Brazil +7 |
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/American Society for Transplantation and Cellular Therapy \[ASTCT\] for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
The MTD or MAD is defined as the highest dose that is tolerable or the highest dose administered, respectively.
The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
| Arm | Type | Description |
|---|---|---|
| Part A (Monotherapy Dose Escalation and Safety Expansion) | EXPERIMENTAL | Ascending dose levels of BGB-B2033 monotherapy |
| Part B (Doublet Run-in) | EXPERIMENTAL | A cohort designed to evaluate the safety and tolerability of BGB-B2033 in combination with tislelizumab and to inform the starting dose of BGB-B2033 for subsequent triplet dose escalation. |
| Part B (Triplet Dose Escalation) | EXPERIMENTAL | Cohorts evaluating BGB-B2033 in combination with tislelizumab and bevacizumab to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDFE) of the combination. |
| Part B (Triplet and Doublet Safety Expansion) | EXPERIMENTAL | Safety expansion arm for each combination therapy cohort (triplet and doublet) |
| Part C (Asia Monotherapy Dose Expansion in HCC) | EXPERIMENTAL | Participants in Asian countries with HCC |
| Part D (US Monotherapy Dose Expansion in HCC) | EXPERIMENTAL | Participants in the United States (US) with HCC |
| Name | Type | Description |
|---|---|---|
| BGB-B2033 | DRUG | Administered by intravenous infusion |
| Tislelizumab | DRUG | Administered by intravenous infusion |
| Bevacizumab | DRUG | Administered by intravenous infusion |
Key Inclusion Criteria: 1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types: 1. Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is...