NCT05359861

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With SRF388 or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Coherus Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 trial composed of an open label Lead-In followed by a Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.

Detailed description

This is a Phase 2 trial designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with atezolizumab plus bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC. After a Lead-In Phase of up to 30 patients who will receive open-label SRF388 + atezolizumab + bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a 1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	SRF388	SRF388 will be administered by intravenous injection (IV)
DRUG	Atezolizumab	Azezolizumab will be administered by IV
DRUG	Bevacizumab	Bevacizumab will be administered by IV
DRUG	Placebo	Placebo will be administered by IV

Timeline

• Start date: 2022-04-12
• Primary completion: 2025-06-30
• Completion: 2025-07-08
• First posted: 2022-05-04
• Last updated: 2026-03-18

Locations

37 sites across 4 countries: United States, Australia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study