A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
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
1 other identifier
interventional
72
6 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Dec 2024
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2024
CompletedFirst Posted
Study publicly available on registry
November 8, 2024
CompletedStudy Start
First participant enrolled
December 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
April 13, 2026
April 1, 2026
2.7 years
November 6, 2024
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
From date of first dose to 90 days after date of last dose (Up to approximately 27 months)
Objective Response Rate (ORR) by Investigator Review According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to approximately 2 years
Secondary Outcomes (11)
ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
Up to approximately 2 years
Duration of Response (DoR) by Investigator Review According to RECIST v1.1
Up to approximately 2 years
DoR by Investigator Review According to HCC mRECIST
Up to approximately 2 years
Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1
Up to approximately 2 years
PFS by Investigator Review According to HCC mRECIST
Up to approximately 2 years
- +6 more secondary outcomes
Study Arms (3)
Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab
EXPERIMENTALArm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab
EXPERIMENTALArm C: Toripalimab + Bevacizumab
ACTIVE COMPARATORInterventions
Solution for infusion
Solution for infusion
Solution for infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259, United States
University of Arizona - Cancer Center
Tucson, Arizona, 85719, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
City of Hope
Duarte, California, 91010, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
Cancer & Blood Specialty Clinic
Lakewood, California, 90712, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
The Winship Cancer Institute Emory University
Atlanta, Georgia, 30322, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, 83712, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
UofL Health Brown Cancer Center
Louisville, Kentucky, 40202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
Columbus, Ohio, 43210, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
UW Carbone Cancer Center - Cancer Connect
Madison, Wisconsin, 53706, United States
Royal Brisbane and Women's Hospital
Herston, Brisbane, 4006, Australia
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
Monash Health
Melbourne, Victoria, 3168, Australia
St Vincent's Hospital Sydney
Darlinghurst, NSW 2010, Australia
Linear Clinical Research
Nedlands, 6009, Australia
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto, Ontario, ON M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, ON M5G 2C4, Canada
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Queen Mary Hospital
Hong Kong, Pok Fu Lam, Hong Kong
Humanity & Health Clinical Trial Centre
Hong Kong, Hong Kong
National Cancer Centre Singapore
Singapore, 168583, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Curie Oncology
Singapore, 329563, Singapore
China Medical University Hospital
Taichung, Taichung City, 404, Taiwan
National Cheng Kung University Hospital
Tainan, Tainan City, 704, Taiwan
National Taiwan University Hospital
Tainan, Taipei City, 100, Taiwan
Taipei Veterans General Hospital
Taipei, Taipei City, 112, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
Linkou Chang Gung Memorial Hospital (CGMHLK)
Taoyuan, 33305, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2024
First Posted
November 8, 2024
Study Start
December 20, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share