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

Purpose

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.

Condition

  • Hepatocellular Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Unresectable locally advanced or metastatic HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic participants. - Disease that is not amenable to curative surgical and/or locoregional therapies or progressive disease (PD) after surgical and/or locoregional therapies. - ≥ 1 measurable lesion (per RECIST v1.1) that is untreated.

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 cholangiocarcinoma and HCC. - Has moderate or severe ascites. - Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Additional protocol-defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab
  • Drug: Casdozokitug
    Solution for infusion
    Other names:
    • CHS-388
  • Drug: Toripalimab
    Solution for infusion
  • Drug: Bevacizumab
    Solution for infusion
Experimental
Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab
  • Drug: Casdozokitug
    Solution for infusion
    Other names:
    • CHS-388
  • Drug: Toripalimab
    Solution for infusion
  • Drug: Bevacizumab
    Solution for infusion
Active Comparator
Arm C: Toripalimab + Bevacizumab
  • Drug: Toripalimab
    Solution for infusion
  • Drug: Bevacizumab
    Solution for infusion

Recruiting Locations

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Jordan Rose
913-574-0015
jrose6@kumc.edu

More Details

Status
Recruiting
Sponsor
Coherus Biosciences, Inc.

Study Contact

Clinical Operations Team
1-800-794-5434
clinicaltrials@coherus.com