Hepatocellular Carcinoma
Conditions
Keywords
Unresectable Hepatocellular Carcinoma, Locally Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma, Casdozokitug, Toripalimab, Bevacizumab, HCC, Liver Cancer, IL-27, PD-1
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.
Interventions
DRUGCasdozokitug
Solution for infusion
DRUGToripalimab
Solution for infusion
DRUGBevacizumab
Solution for infusion
Sponsors
Coherus Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1 | Up to approximately 2 years |
| DCR by Investigator Review According to HCC mRECIST | Up to approximately 2 years |
| Overall Survival (OS) | Up to approximately 2 years |
| Maximum Concentration (Cmax) | Up to approximately 25 months |
| Minimum Concentration (Cmin) | Up to approximately 25 months |
| Time to Cmax (Tmax) | Up to approximately 25 months |
Countries
Australia, Canada, Hong Kong, Singapore, Taiwan, United States
Contacts
STUDY_DIRECTORStudy Director
Coherus Oncology
Outcome results
None listed