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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06679985




Registration number
NCT06679985
Ethics application status
Date submitted
6/11/2024
Date registered
8/11/2024
Date last updated
24/08/2025

Titles & IDs
Public title
A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
Scientific 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
Secondary ID [1] 0 0
CHS-388-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Casdozokitug
Treatment: Drugs - Toripalimab
Treatment: Drugs - Bevacizumab

Experimental: Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab -

Experimental: Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab -

Active comparator: Arm C: Toripalimab + Bevacizumab -


Treatment: Drugs: Casdozokitug
Solution for infusion

Treatment: Drugs: Toripalimab
Solution for infusion

Treatment: Drugs: Bevacizumab
Solution for infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From date of first dose to 90 days after date of last dose (Up to approximately 27 months)
Primary outcome [2] 0 0
Objective Response Rate (ORR) by Investigator Review According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Duration of Response (DoR) by Investigator Review According to RECIST v1.1
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
DoR by Investigator Review According to HCC mRECIST
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
PFS by Investigator Review According to HCC mRECIST
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
DCR by Investigator Review According to HCC mRECIST
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Maximum Concentration (Cmax)
Timepoint [9] 0 0
Up to approximately 25 months
Secondary outcome [10] 0 0
Minimum Concentration (Cmin)
Timepoint [10] 0 0
Up to approximately 25 months
Secondary outcome [11] 0 0
Time to Cmax (Tmax)
Timepoint [11] 0 0
Up to approximately 25 months

Eligibility
Key inclusion criteria
Key

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Brisban
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
NSW 2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Hong Kong
State/province [16] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Coherus Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Operations Team
Address 0 0
Country 0 0
Phone 0 0
1-800-794-5434
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06679985