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Back|NCT06679985Recruiting
Official Title

A Randomized Phase 2 Study of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma

Phase
Phase 2
Sponsor
Coherus Oncology, Inc.
Enrollment
72
Timeline
Dec 2024 → Sep 2027
About This Study

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 Criteria

  • 1Unresectable 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.
  • 2Disease that is not amenable to curative surgical and/or locoregional therapies or progressive disease (PD) after surgical and/or locoregional therapies.
  • 3≥ 1 measurable lesion (per RECIST v1.1) that is untreated.

Exclusion Criteria

  • 1Has received prior systemic therapy for HCC.
  • 2Has previously received an anti-IL-27 antibody (Ab) or anti-IL-27-targeted therapy.
  • 3Has known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • 4Has moderate or severe ascites.
  • 5Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).

Locations

41 sites participating in this study

The Winship Cancer Institute Emory University

Atlanta, Georgia 30322

Recruiting

Lindsay Hannan, MD

Mayo Clinic - Scottsdale

Scottsdale, Arizona 85259

Recruiting

Daniel Ahn, MD

University of Arizona - Cancer Center

Tucson, Arizona 85719

Recruiting

Junaid Arshad, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →