Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma
NCT ID: NCT05359861
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2022-04-12
2025-07-08
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lead-In
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.
SRF388
SRF388 will be administered by intravenous injection (IV)
Atezolizumab
Azezolizumab will be administered by IV
Bevacizumab
Bevacizumab will be administered by IV
Arm A: SRF388 in Combination with atezolizumab plus bevacizumab
Patients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.
SRF388
SRF388 will be administered by intravenous injection (IV)
Atezolizumab
Azezolizumab will be administered by IV
Bevacizumab
Bevacizumab will be administered by IV
Arm B: Placebo in combination with atezolizumab plus bevacizumab
Patients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.
Atezolizumab
Azezolizumab will be administered by IV
Bevacizumab
Bevacizumab will be administered by IV
Placebo
Placebo will be administered by IV
Interventions
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SRF388
SRF388 will be administered by intravenous injection (IV)
Atezolizumab
Azezolizumab will be administered by IV
Bevacizumab
Bevacizumab will be administered by IV
Placebo
Placebo will be administered by IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Coherus Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Koho Iizuka, MD
Role: STUDY_CHAIR
Coherus Oncology, Inc.
Locations
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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
The Alfred Hospital
Melbourne, , Australia
Royal Melbourne Hospital
Melbourne, , Australia
St George Hospital -Kogarah
NSW, , 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
Countries
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Other Identifiers
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SRF388-201
Identifier Type: -
Identifier Source: org_study_id