Combination treatment for advanced liver cancer
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
This study is testing a new combination of treatments for people with advanced liver cancer to see if it works better and what the best dose is.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coherus Biosciences, Inc. Industry-sponsored |
| Drugs / interventions | toripalimab, bevacizumab |
| Locations | 11 sites (Beverly Hills, California and 10 other locations) |
| Trial ID | NCT06679985 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of casdozokitug when used alongside toripalimab and bevacizumab in patients with unresectable or advanced metastatic hepatocellular carcinoma. The study aims to determine the optimal dosage of casdozokitug in this combination therapy. Participants will be monitored for treatment response and any adverse effects throughout the trial. The approach focuses on patients whose cancer cannot be surgically removed or has progressed after other treatments.
Who should consider this trial
Good fit: Ideal candidates include individuals with unresectable locally advanced or metastatic hepatocellular carcinoma who have measurable lesions and have not received prior systemic therapy.
Not a fit: Patients with specific histological types of liver cancer, such as fibrolamellar HCC or those with severe ascites, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating advanced liver cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beverly Hills, California and 10 other locations
- Beverly Hills Cancer Center — Beverly Hills, California, United States (Recruiting)
- City of Hope — Duarte, California, United States (Recruiting)
- City of Hope at Irvine Lennar — Irvine, California, United States (Recruiting)
- Cancer & Blood Specialty Clinic — Lakewood, California, United States (Recruiting)
- Sarcoma Oncology Center — Santa Monica, California, United States (Recruiting)
- Mountain States Tumor Institute at St. Luke's Regional Medical Center — Boise, Idaho, United States (Recruiting)
- University of Kansas Cancer Center — Kansas City, Kansas, United States (Recruiting)
- Christus St. Vincent Regional Medical Center — Santa Fe, New Mexico, United States (Recruiting)
- Prisma Health Cancer Institute — Greenville, South Carolina, United States (Recruiting)
- Virginia Oncology Associates — Norfolk, Virginia, United States (Recruiting)
- University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Operations Team
- Email: clinicaltrials@coherus.com
- Phone: 1-800-794-5434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.