A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma

Last updated: January 6, 2026
Sponsor: Coherus Oncology, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer/tumors

Cancer

Liver Disorders

Treatment

Bevacizumab

Casdozokitug

Toripalimab

Clinical Study ID

NCT06679985
CHS-388-202
  • Ages > 18
  • All Genders

Study Summary

The main goals of this study are to evaluate the safety and efficacy of casdozokitug in combination with toripalimab plus bevacizumab and to define a recommended dose for casdozokitug in combination with toripalimab plus bevacizumab.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Unresectable locally advanced or metastatic HCC with diagnosis confirmed byhistology/cytology or clinically by American Association for the Study of LiverDiseases criteria in cirrhotic participants.

  • Disease that is not amenable to curative surgical and/or locoregional therapies orprogressive disease (PD) after surgical and/or locoregional therapies.

  • ≥ 1 measurable lesion (per RECIST v1.1) that is untreated.

Exclusion

Exclusion Criteria:

  • Has received prior systemic therapy for HCC.

  • Has previously received an anti-IL-27 antibody (Ab) or anti-IL-27-targeted therapy.

  • Has known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinomaand HCC.

  • Has moderate or severe ascites.

  • Has uncontrolled pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures (once monthly or more frequently).

Additional protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: Bevacizumab
Phase: 2
Study Start date:
December 20, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Royal Brisbane and Women's Hospital

    Herston, Brisbane 4006
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston 6931014, Brisbane 4006
    Australia

    Active - Recruiting

  • Bankstown-Lidcombe Hospital

    Bankstown 2176947, New South Wales 2155400 2200
    Australia

    Active - Recruiting

  • Monash Health

    Melbourne 2158177, Victoria 2145234 3168
    Australia

    Active - Recruiting

  • St Vincent's Hospital Sydney

    Darlinghurst, NSW 2010
    Australia

    Site Not Available

  • St Vincent's Hospital Sydney

    Darlinghurst 2169378, NSW 2010
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands 2064874, 6009
    Australia

    Active - Recruiting

  • Princess Margaret Hospital

    Toronto 6167865, Ontario 6093943 ON M5G 2C4
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre - Bayview Campus

    Toronto 6167865, Ontario 6093943 ON M4N 3M5
    Canada

    Active - Recruiting

  • Prince of Wales Hospital

    Shatin 1818920, New Territories
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong 1819729, Pok Fu Lam
    Hong Kong

    Active - Recruiting

  • Humanity & Health Clinical Trial Centre

    Hong Kong,
    Hong Kong

    Site Not Available

  • Humanity & Health Clinical Trial Centre

    Hong Kong 1819729,
    Hong Kong

    Active - Recruiting

  • Curie Oncology

    Singapore 1880252, 329563
    Singapore

    Active - Recruiting

  • National Cancer Centre Singapore

    Singapore 1880252, 168583
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore 1880252, 308433
    Singapore

    Active - Recruiting

  • China Medical University Hospital

    Taichung 1668399, Taichung City 404
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan 1668355, Tainan City 704
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan City 1668355, Tainan City 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Tainan 1668355, Taipei City 100
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Tainan City 1668355, Taipei City 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, Taipei City 112
    Taiwan

    Active - Recruiting

  • Chi Mei Medical Center

    Tainan 1668355, 71004
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan 6696918, 33305
    Taiwan

    Active - Recruiting

  • University of Arizona - Cancer Center

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Mayo Clinic - Scottsdale

    Scottsdale 5313457, Arizona 5551752 85259
    United States

    Active - Recruiting

  • University of Arizona - Cancer Center

    Tucson 5318313, Arizona 5551752 85719
    United States

    Active - Recruiting

  • Beverly Hills Cancer Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope at Irvine Lennar

    Irvine, California 92618
    United States

    Site Not Available

  • Cancer & Blood Specialty Clinic

    Lakewood, California 90712
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Site Not Available

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Site Not Available

  • Beverly Hills Cancer Center

    Beverly Hills 5328041, California 5332921 90211
    United States

    Active - Recruiting

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • City of Hope at Irvine Lennar

    Irvine 5359777, California 5332921 92618
    United States

    Active - Recruiting

  • Cancer & Blood Specialty Clinic

    Lakewood 5364855, California 5332921 90712
    United States

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90089
    United States

    Active - Recruiting

  • Sarcoma Oncology Center

    Santa Monica 5393212, California 5332921 90403
    United States

    Active - Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Active - Recruiting

  • The Winship Cancer Institute Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • The Winship Cancer Institute Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise, Idaho 83712
    United States

    Site Not Available

  • Mountain States Tumor Institute at St. Luke's Regional Medical Center

    Boise 5586437, Idaho 5596512 83712
    United States

    Active - Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Cancer Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Active - Recruiting

  • UofL Health Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • UofL Health Brown Cancer Center

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson 4431410, Mississippi 4436296 39216
    United States

    Active - Recruiting

  • Christus St. Vincent Regional Medical Center

    Santa Fe, New Mexico 87505
    United States

    Site Not Available

  • Christus St. Vincent Regional Medical Center

    Santa Fe 5490263, New Mexico 5481136 87505
    United States

    Active - Recruiting

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • University of North Carolina (UNC) - Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina (UNC) - Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Prisma Health Cancer Institute

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Active - Recruiting

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin 53706
    United States

    Site Not Available

  • UW Carbone Cancer Center - Cancer Connect

    Madison 5261457, Wisconsin 5279468 53706
    United States

    Active - Recruiting

  • University of Wisconsin - Carbone Cancer Center

    Madison 5261457, Wisconsin 5279468 53706
    United States

    Active - Recruiting

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