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.
Brief Title
A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-800-794-5434
Central Contact Email
clinicaltrials@coherus.com
Completion Date
Completion Date Type
Estimated
Conditions
Hepatocellular Carcinoma
Eligibility 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.
* 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.
Inclusion Criteria
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.
inclusion/
* 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.
inclusion/
Gender
All
Gender Based
false
Keywords
Unresectable Hepatocellular Carcinoma
Locally Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Casdozokitug
Toripalimab
Bevacizumab
HCC
Liver Cancer
IL-27
PD-1
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06679985
Org Class
Industry
Org Full Name
Coherus Oncology, Inc.
Org Study Id
CHS-388-202
Overall Status
Recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Outcome Time Frame
From date of first dose to 90 days after date of last dose (Up to approximately 27 months)
Outcome Measure
Objective Response Rate (ORR) by Investigator Review According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Outcome Time Frame
Up to approximately 2 years
Secondary Outcomes
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
Duration of Response (DoR) by Investigator Review According to RECIST v1.1
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
DoR by Investigator Review According to HCC mRECIST
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
PFS by Investigator Review According to HCC mRECIST
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
DCR by Investigator Review According to HCC mRECIST
Outcome Time Frame
Up to approximately 2 years
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Up to approximately 25 months
Outcome Measure
Maximum Concentration (Cmax)
Outcome Time Frame
Up to approximately 25 months
Outcome Measure
Minimum Concentration (Cmin)
Outcome Time Frame
Up to approximately 25 months
Outcome Measure
Time to Cmax (Tmax)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andreas Kaubisch
Investigator Email
akaubisc@montefiore.org
Investigator Phone
718-920-7100
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Endocrine System Cancers --- ADENOCARCINOMA
Cancer --- CARCINOMA
Lung & Chest Cancers --- NEOPLASMS, GLANDULAR AND EPITHELIAL
Cancer --- NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Digestive System --- LIVER DISEASES
Liver --- LIVER DISEASES
MeSH Terms
CARCINOMA, HEPATOCELLULAR
LIVER NEOPLASMS
ADENOCARCINOMA
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
DIGESTIVE SYSTEM DISEASES
LIVER DISEASES
TORIPALIMAB
BEVACIZUMAB
ANTIBODIES, MONOCLONAL, HUMANIZED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
SERUM GLOBULINS
GLOBULINS