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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05359861 | Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma | PHASE2 | COMPLETED | 30 | — | — | Apr 12, 2022 | Jul 8, 2025 | Mar 18, 2026 | 37 | United States, Australia +2 |
Summaries of AEs will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study drug to 30 days after the last dose of study drug (Lead-In Phase).
PFS according to RECIST v1.1 will be evaluated in patients receiving SRF388 in combination with atezolizumab plus bevacizumab compared to placebo in combination with atezolizumab plus bevacizumab (Randomized Phase).
| Arm | Type | Description |
|---|---|---|
| Lead-In | EXPERIMENTAL | A minimum of 6 patients and up to 30 patients will be enrolled in an open-label Lead-In to assess the preliminary safety and tolerability of SRF388 with atezolizumab plus bevacizumab. |
| Arm A: SRF388 in Combination with atezolizumab plus bevacizumab | EXPERIMENTAL | Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab. |
| Arm B: Placebo in combination with atezolizumab plus bevacizumab | EXPERIMENTAL | Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab. |
| Name | Type | Description |
|---|---|---|
| SRF388 | DRUG | SRF388 will be administered by intravenous injection (IV) |
| Atezolizumab | DRUG | Azezolizumab will be administered by IV |
| Bevacizumab | DRUG | Bevacizumab will be administered by IV |
| Placebo | DRUG | Placebo will be administered by IV |
Abbreviated Inclusion Criteria: * ≥ 18 years of age on day of signing informed consent * Unresectable locally advanced or metastatic HCC * No prior systemic treatment for unresectable locally advanced or metastatic HCC * BCLC Stage B or Stage C disease * Child-Pugh Class A disease * ≥ 1 measurable ...