Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT05359861

PHASE2

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-04-12

Completion Date

2025-07-08

Last Updated

2026-06-29

Healthy Volunteers

Conditions

Hepatocellular Carcinoma

Interventions

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

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 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 Abbreviated 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. * Active or history of autoimmune disease or immune deficiency with some exceptions such as controlled thyroid disease, Type 1 diabetes, eczema and other minor skin disorders. * Medical conditions requiring chronic steroid therapy (ie, \> 10 mg/day of prednisone or its equivalent) or anticipates the need for systemic immunosuppressive medications during treatment with study drug * Known active infection with HIV * Known infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), except for controlled active HBV or fully treated HCV infection as defined by the protocol * Inadequately controlled arterial hypertension

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

NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI))

New York, New York, United States

University of Oklahoma Health Sciences Center - Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Providence Portland Medical Center

Portland, Oregon, United States

Sarah Cannon Research Institute - Tennessee Oncology

Chattanooga, Tennessee, United States

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, United States

St George Hospital -Kogarah

Kogarah, Australia

The Alfred Hospital

Melbourne, Australia

Royal Melbourne Hospital

Melbourne, Australia

Gold Coast Private Hospital

Southport, Australia

The Catholic University of Korea - St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Daegu Catholic University Medical Center (DCUMC)

Daegu, South Korea

Chonnam National University (CNU) - Chonnam National University Hwasun Hospital (CNUHH)

Gwangju, South Korea

Ajou University Hospital

Gyeonggi-do, South Korea

CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Severance Hospital

Seoul, South Korea

Gangnam Severance Hospital - Cancer Hospital

Seoul, South Korea

Korea University Medical Center - Korea University Anam Hospital

Seoul, South Korea

University of Ulsan College of Medicine - Asan Medical Center (AMC)

Seoul, South Korea

Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Buddhist Tzu Chi General Hospital - Hualien Tzu Chi Medical Center

Hualien City, Taiwan

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

E-Da Cancer Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (37)