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

Launched by COHERUS BIOSCIENCES, INC. · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a specific type of liver cancer called hepatocellular carcinoma (HCC), which is either too advanced or cannot be removed by surgery. The treatment being tested combines three medications: casdozokitug, toripalimab, and bevacizumab. The main goals of the study are to see how safe this combination is for patients and how well it works in treating their cancer. Researchers are also trying to find the best dose of casdozokitug to use in this combination.

To participate in this trial, patients need to have a confirmed diagnosis of advanced HCC that can’t be treated with surgery or other local therapies. They should have at least one measurable tumor that hasn't been treated yet. However, patients who have previously received certain treatments for their liver cancer or have specific liver conditions may not be eligible. Those who join the trial can expect regular visits for assessments and treatment, and they will be closely monitored for any side effects. This study is currently recruiting participants, and both men and women aged 65 to 74 are welcome to apply.

Gender

ALL

Eligibility criteria

• Key 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.