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Hepatocellular CarcinomaPhase 2NCT05359861

Trial of Atezolizumab and Bevacizumab With CHS-388 or Placebo in Patients With Hepatocellular Carcinoma

A Phase 2 study testing Casdozokitug, Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma, run by Coherus Oncology, Inc. at 37 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This was a Phase 2 trial composed of an open label Lead-In followed by a planned 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Casdozokitug, Atezolizumab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
37 sitesin 4 countries
Study dates
12 Apr 2022to 8 Jul 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

37 sites in 4 countries.

37 sites in 4 countries

United States15 sites

  • Veterans Affairs Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

  • University of Michigan Health System (UMHS)

    Ann Arbor, Michigan, 48109

  • Sarah Cannon Research Institute - Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • University of Southern California - Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Louisville VA Medical Center - Robley Rex VA Medical Center

    Louisville, Kentucky, 40206

  • University of Miami, Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee, 37203

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

    New York, New York, 10010

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

    New York, New York, 10016

  • University of Oklahoma Health Sciences Center - Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

Other trials in United States

South Korea12 sites

  • Daegu Catholic University Medical Center (DCUMC)

    Daegu, 705-718

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

    Gwangju, 58128

  • Ajou University Hospital

    Gyeonggi-do, 443-721

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

    Gyeonggi-do, 463-712

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Severance Hospital

    Seoul, 03722

  • Gangnam Severance Hospital - Cancer Hospital

    Seoul, 135-720

  • Korea University Medical Center - Korea University Anam Hospital

    Seoul, 136-705

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

    Seoul, 138-736

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

    Seoul, 156-707

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

    Suwon, Gyeonggi-do, 442-723

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Taiwan6 sites

  • Buddhist Tzu Chi General Hospital - Hualien Tzu Chi Medical Center

    Hualien City, 970

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • E-Da Cancer Hospital

    Kaohsiung City, 82445

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Australia4 sites

  • St George Hospital -Kogarah

    Kogarah, 2217

  • The Alfred Hospital

    Melbourne, 3004

  • Royal Melbourne Hospital

    Melbourne

  • Gold Coast Private Hospital

    Southport, 4215

Other trials in Australia

About this study

Official title: A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With CHS-388 (Formerly Known as SRF388) or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma.

This was a Phase 2 trial composed of an open label Lead-In followed by a planned 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.

Only the Lead-In Phase of the study was completed.

Read the 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).

Being tested
Casdozokitug, Atezolizumab, Bevacizumab, Placebo
Keywords
Phase 2, SRF388, IL-27, safety, efficacy, immunotherapy, cancer, immuno-oncology, liver cancer, hepatocellular carcinoma, atezolizumab, Tecentriq, bevacizumab, Avastin
Medical subject headings
Carcinoma, Hepatocellular, Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CasdozokitugDrug

    Also called CHS-388, SRF388

    Casdozokitug will be administered by intravenous injection (IV)

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered by IV

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered by IV

  • PlaceboDrug

    Placebo will be administered by IV

Study groups in NCT05359861
Study groupRoleWhat they receive
Lead-InExperimentalA 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.
Receives: Drug: Casdozokitug; Drug: Atezolizumab; Drug: Bevacizumab
Arm A: SRF388 in Combination with atezolizumab plus bevacizumabExperimentalPatients randomized to Arm A will receive SRF388 with atezolizumab plus bevacizumab.
Receives: Drug: Casdozokitug; Drug: Atezolizumab; Drug: Bevacizumab
Arm B: Placebo in combination with atezolizumab plus bevacizumabExperimentalPatients randomized to Arm B will receive placebo with atezolizumab plus bevacizumab.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    A TEAE was defined as an AE that emerged or worsened in the period from the first dose of study drug to 30 days after the last dose of study drug. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in the Reported AE section.

    Measured: Up to approximately 37 months

Secondary outcomes (18)

  1. Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    PFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to RECIST v1.1 or death due to any cause, whichever occured first. Disease progression was defined according to RECIST v1.1 criteria, including at least a 20% increase in the sum of diameters of target lesions relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 millimeters (mm), or the appearance of one or more new lesions.

    Measured: Up to approximately 38 months

  2. PFS According to Hepatocellular Carcinoma Modified RECIST (HCC mRECIST) (mPFS)

    mPFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to HCC mRECIST or death due to any cause, whichever occured first. Disease progression was defined per HCC mRECIST criteria, including at least a 20% increase in the sum of diameters of target lesions (including viable tumor diameters for typical intrahepatic target lesions and short axis diameters for nodal lesions) relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 mm.

    Measured: Up to approximately 38 months

  3. Objective Response Rate (ORR) According to RECIST v1.1

    ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST v1.1.

    • CR: Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to < 10 mm in short axis.
    • PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 38 months

  4. ORR According to HCC mRECIST (mORR)

    mORR was defined as the percentage of participants achieving complete response CR and PR per HCC mRECIST.

    • CR: Disappearance of any intratumoral arterial enhancement in all target lesions.. All pathological lymph nodes must have decreased to < 10 mm in short axis.
    • PR: At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions. target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 38 months

  5. Duration of Response (DoR) According to RECIST 1.1

    DoR was defined as the time from first documentation of CR or PR until the time of the first documentation of PD evaluated using RECIST v1.1 or death due to any cause.

    Measured: Up to approximately 38 months

  6. DoR According to HCC mRECIST (mDoR)

    mDoR was defined as the time from first documentation of CR or PR until the time of the first documentation of PD evaluated using HCC mRECIST or death due to any cause.

    Measured: Up to approximately 38 months

  7. Disease Control Rate (DCR) According to RECIST v1.1

    DCR was defined as the percentage of participants who achieved CR, PR, or SD according to RECIST v1.1 for at least 12 weeks.

    Measured: Up to approximately 38 months

  8. DCR According to HCC mRECIST (mDCR)

    mDCR was defined as the percentage of participants who achieved CR, PR, or SD according to HCC mRECIST for at least 12 weeks.

    Measured: Up to approximately 38 months

  9. Time to Progression (TTP) According to RECIST v1.1

    TTP was defined as time from study drug initiation to the occurrence of disease progression per RECIST v1.1.

    Measured: Up to approximately 38 months

  10. TTP According to HCC mRECIST (mTTP)

    mTTP was defined as time from study drug initiation to the occurrence of disease progression per HCC mRECIST.

    Measured: Up to approximately 38 months

  11. Overall Survival (OS)

    OS was defined as the time from study drug initiation to death from any cause.

    Measured: Up to approximately 38 months

  12. Time to Response (TTR) According to RECIST v1.1

    TTR was defined as the time from study drug initiation to initial documented objective response per RECIST v1.1.

    Measured: Up to approximately 38 months

  13. TTR According to HCC mRECIST (mTTR)

    mTTR was defined as the time from study drug initiation to initial documented objective response per HCC mRECIST.

    Measured: Up to approximately 38 months

  14. Time on Therapy

    Time on therapy was defined as the time from study drug initiation to last treatment.

    Measured: Up to approximately 38 months

  15. Mean Serum Epstein-Barr Virus Induced Gene 3 (EBI3) Concentration by Best Overall Response (BOR) According to RECIST v1.1

    Baseline Serum EBI3 was collected and is reported by BOR status per RECIST v1.1.

    • CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in the short axis to <10 mm.
    • PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
    • PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.)
    • Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Baseline up to approximately 38 months

  16. PFS According to RECIST v1.1 by Baseline Serum EBI3 Status

    PFS was defined as the time from the date of randomization to the first documented evidence of disease progression as assessed according to RECIST v1.1 or death due to any cause, whichever occured first. Disease progression was defined according to RECIST v1.1 criteria, including at least a 20% increase in the sum of diameters of target lesions relative to the smallest sum recorded during the study, with an absolute increase in the sum of diameters of at least 5 millimeters (mm), or the appearance of one or more new lesions.

    Measured: Up to approximately 38 months

  17. TTP According to RECIST v1.1 by Baseline Serum EBI3 Status

    TTP was defined as time from study drug initiation to the occurrence of disease progression per RECIST v1.1.

    Measured: Up to approximately 38 months

  18. OS by Baseline Serum EBI3 Status

    OS was defined as the time from study drug initiation to death from any cause.

    Measured: Up to approximately 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start12 Apr 2022
  3. Primary completion30 Jun 2025
  4. Study completion8 Jul 2025

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05359861
Sponsor's protocol ID
SRF388-201
Status last verified
Sep 2026
First submitted
14 Apr 2022
Last updated
1 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Casdozokitug, Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma, run by Coherus Oncology, Inc. at 37 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, South Korea, Taiwan, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 37 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05359861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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