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Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05359861•Coherus Oncology, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 lesion per RECIST v1.1
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Laboratory values indicative of adequate organ function as defined in the protocol
•Women of childbearing potential must have a negative pregnancy test within 1 week prior to first dose of study drug
•Women of childbearing potential or men with a heterosexual partner of childbearing potential or pregnant must agree to refrain from sexual intercourse or be willing to use effective methods of contraception as defined in the protocol while receiving study drug and for 6 months after the last dose of any study drug

Exclusion Criteria

•Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
•Previously received an anti-interleukin (IL)-27 antibody (Ab) or anti-IL-27-targeted therapy.
•Received prior systemic therapy for unresectable or metastatic disease. (Note: Prior systemic therapies administered for neoadjuvant, adjuvant, or curative intent (localized disease) are permitted if they were given \> 1 year prior to the development of recurrent or metastatic disease)
•Known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
•Moderate or severe ascites
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
•History of or current hepatic encephalopathy
•Unable to undergo disease evaluation with a triphasic CT or MRI because of contrast allergy or other contraindication
•Untreated or incompletely treated varices with bleeding or high risk for bleeding.
•Symptomatic or untreated brain metastases or leptomeningeal carcinomatosis.
+5 more criteria

Locations (37)

University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Louisville VA Medical Center - Robley Rex VA Medical Center

Louisville, Kentucky, United States

Veterans Affairs Ann Arbor Healthcare System

Ann Arbor, Michigan, United States

University of Michigan Health System (UMHS)

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center

New York, New York, United States

Key Dates

Start Date

April 12, 2022

Primary Completion Date

June 30, 2025

Completion Date

July 8, 2025

Last Updated

March 18, 2026

Enrollment

ACTUAL participants

Conditions

Hepatocellular Carcinoma

Interventions

SRF388

DRUG

Atezolizumab

DRUG

Bevacizumab

DRUG

Placebo

DRUG

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

View study

RECRUITING

Early Detection of Liver Cancer by QUS

NCT06345508

Hepatocellular CarcinomaLiver Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Early Detection of Liver Cancer by QUS

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)