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

Last updated: July 9, 2025
Sponsor: Coherus Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer/tumors

Abdominal Cancer

Carcinoma

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

  • Beverly Hills Cancer Center

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California 92618
    United States

    Active - Recruiting

  • Cancer & Blood Specialty Clinic

    Lakewood, California 90712
    United States

    Active - Recruiting

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Active - Recruiting

  • The Winship Cancer Institute Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

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

    Boise, Idaho 83712
    United States

    Active - Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Christus St. Vincent Regional Medical Center

    Santa Fe, New Mexico 87505
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 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, Ohio 43210
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin 53706
    United States

    Active - Recruiting

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