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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab |
|
|
|
Experimental Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab |
|
|
|
Active Comparator Arm C: Toripalimab + Bevacizumab |
|
Recruiting Locations
Beverly Hills Cancer Center
Beverly Hills, California 90211
Beverly Hills, California 90211
City of Hope at Irvine Lennar
Irvine, California 92618
Irvine, California 92618
Cancer & Blood Specialty Clinic
Lakewood, California 90712
Lakewood, California 90712
Sarcoma Oncology Center
Santa Monica, California 90403
Santa Monica, California 90403
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho 83712
Boise, Idaho 83712
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico 87505
Santa Fe, New Mexico 87505
Virginia Oncology Associates
Norfolk, Virginia 23502
Norfolk, Virginia 23502
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin 53706
Madison, Wisconsin 53706
More Details
- NCT ID
- NCT06679985
- Status
- Recruiting
- Sponsor
- Coherus Biosciences, Inc.