RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-12-20
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06679985

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Disease 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.
  1. * Has received prior systemic therapy for HCC.
  2. * Has previously received an anti-IL-27 antibody (Ab) or anti-IL-27-targeted therapy.
  3. * Has known fibrolamellar HCC histology, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  4. * Has moderate or severe ascites.
  5. * Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).

Contacts and Locations

Study Contact

Hillary O'Kelly, MPH
CONTACT
1-800-794-5434
hokelly@coherus.com

Study Locations (Sites)

Sarcoma Oncology Center
Santa Monica, California, 90403
United States

Collaborators and Investigators

Sponsor: Coherus Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-20
Study Completion Date2027-09

Study Record Updates

Study Start Date2024-12-20
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Unresectable Hepatocellular Carcinoma
  • Locally Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Casdozokitug
  • Toripalimab
  • Bevacizumab
  • HCC
  • Liver Cancer
  • IL-27
  • PD-1

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma