Hepatocellular CarcinomaPhase 2NCT06679985
A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
A Phase 2 study testing Casdozokitug, Toripalimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Coherus Oncology, Inc. at 44 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Casdozokitug, Toripalimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 20 Dec 2024to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
United States25 sites
The Winship Cancer Institute Emory University
Atlanta, Georgia, 30322
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, 83712
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina, 27599
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
City of Hope at Irvine Lennar
Irvine, California, 92618
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Cancer & Blood Specialty Clinic
Lakewood, California, 90712
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
UofL Health Brown Cancer Center
Louisville, Kentucky, 40202
UW Carbone Cancer Center - Cancer Connect
Madison, Wisconsin, 53706
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Virginia Oncology Associates
Norfolk, Virginia, 23502
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505
Sarcoma Oncology Center
Santa Monica, California, 90403
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
Montefiore Medical Center
The Bronx, New York, 10467
University of Arizona - Cancer Center
Tucson, Arizona, 85719
Taiwan6 sites
China Medical University Hospital
Taichung, Taichung City, 404
National Cheng Kung University Hospital
Tainan, Tainan City, 704
National Taiwan University Hospital
Tainan, Taipei City, 100
Chi Mei Medical Center
Tainan, 71004
Taipei Veterans General Hospital
Taipei, Taipei City, 112
Linkou Chang Gung Memorial Hospital (CGMHLK)
Taoyuan City, 33305
Australia5 sites
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200
St Vincent's Hospital Sydney
Darlinghurst, NSW 2010
Royal Brisbane and Women's Hospital
Herston, Brisbane, 4006
Monash Health
Melbourne, Victoria, 3168
Linear Clinical Research
Nedlands, 6009
Hong Kong3 sites
Queen Mary Hospital
Hong Kong, Pok Fu Lam
Humanity & Health Clinical Trial Centre
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
Singapore3 sites
National Cancer Centre Singapore
Singapore, 168583
Tan Tock Seng Hospital
Singapore, 308433
Curie Oncology
Singapore, 329563
Canada2 sites
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto, Ontario, ON M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, ON M5G 2C4
About this study
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
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Casdozokitug, Toripalimab, Bevacizumab
- Keywords
- Unresectable Hepatocellular Carcinoma, Locally Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma, Casdozokitug, Toripalimab, Bevacizumab, HCC, Liver Cancer, IL-27, PD-1
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CasdozokitugDrug
Also called CHS-388
Solution for infusion
ToripalimabDrug
Solution for infusion
BevacizumabDrug
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab | Experimental | Not described Receives: Drug: Casdozokitug; Drug: Toripalimab; Drug: Bevacizumab |
| Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab | Experimental | Not described Receives: Drug: Casdozokitug; Drug: Toripalimab; Drug: Bevacizumab |
| Arm C: Toripalimab + Bevacizumab | Active comparator | Not described Receives: Drug: Toripalimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: 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
Measured: Up to approximately 2 years
Secondary outcomes (11)
ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
Measured: Up to approximately 2 years
Duration of Response (DoR) by Investigator Review According to RECIST v1.1
Measured: Up to approximately 2 years
DoR by Investigator Review According to HCC mRECIST
Measured: Up to approximately 2 years
Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1
Measured: Up to approximately 2 years
PFS by Investigator Review According to HCC mRECIST
Measured: Up to approximately 2 years
Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1
Measured: Up to approximately 2 years
DCR by Investigator Review According to HCC mRECIST
Measured: Up to approximately 2 years
Overall Survival (OS)
Measured: Up to approximately 2 years
Maximum Concentration (Cmax)
Measured: Up to approximately 25 months
Minimum Concentration (Cmin)
Measured: Up to approximately 25 months
Time to Cmax (Tmax)
Measured: Up to approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start20 Dec 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coherus Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Coherus Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679985
- Sponsor's protocol ID
- CHS-388-202
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06679985
- Acronym / sponsor ID
- CHS-388-202
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Unresectable Hepatocellular Carcinoma, Locally Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma, Casdozokitug, Toripalimab, Bevacizumab, HCC, Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Coherus Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab | Experimental | Drug: Casdozokitug, Drug: Toripalimab, Drug: Bevacizumab |
| Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab | Experimental | Drug: Casdozokitug, Drug: Toripalimab, Drug: Bevacizumab |
| Arm C: Toripalimab + Bevacizumab | Active comparator | Drug: Toripalimab, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CasdozokitugAlso: CHS-388Solution for infusion | Drug | Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab, Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab |
| ToripalimabSolution for infusion | Drug | Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab, Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab, Arm C: Toripalimab + Bevacizumab |
| BevacizumabSolution for infusion | Drug | Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab, Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab, Arm C: Toripalimab + Bevacizumab |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: 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
Time frame: Up to approximately 2 years
11 secondary outcomes
ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
Time frame: Up to approximately 2 years
Duration of Response (DoR) by Investigator Review According to RECIST v1.1
Time frame: Up to approximately 2 years
DoR by Investigator Review According to HCC mRECIST
Time frame: Up to approximately 2 years
Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1
Time frame: Up to approximately 2 years
PFS by Investigator Review According to HCC mRECIST
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1
Time frame: Up to approximately 2 years
DCR by Investigator Review According to HCC mRECIST
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Maximum Concentration (Cmax)
Time frame: Up to approximately 25 months
Minimum Concentration (Cmin)
Time frame: Up to approximately 25 months
Time to Cmax (Tmax)
Time frame: Up to approximately 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Coherus Oncology
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Casdozokitug, Toripalimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Coherus Oncology, Inc. at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Taiwan, Australia, Hong Kong, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: From date of first dose to 90 days after date of last dose (Up to approximately 27 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.