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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab
  • Drug: Casdozokitug
    Solution for infusion
    Other names:
    • CHS-388
  • Drug: Toripalimab
    Solution for infusion
  • Drug: Bevacizumab
    Solution for infusion
Experimental
Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab
  • Drug: Casdozokitug
    Solution for infusion
    Other names:
    • CHS-388
  • Drug: Toripalimab
    Solution for infusion
  • Drug: Bevacizumab
    Solution for infusion
Active Comparator
Arm C: Toripalimab + Bevacizumab
  • Drug: Toripalimab
    Solution for infusion
  • Drug: Bevacizumab
    Solution for infusion

Recruiting Locations

Mayo Clinic - Scottsdale
Scottsdale 5313457, Arizona 5551752 85259
Contact:
Jose Silva
480-342-5083
Silva.Jose2@mayo.edu

University of Arizona - Cancer Center
Tucson 5318313, Arizona 5551752 85719
Contact:
Prisca Zimmerman
priscaz@arizona.edu

Beverly Hills Cancer Center
Beverly Hills 5328041, California 5332921 90211
Contact:
Diana Amaya
310-432-8900
Damaya@BHCancercenter.com

City of Hope
Duarte 5344147, California 5332921 91010
Contact:
Steven Carrasco
scarrasco@coh.org

City of Hope at Irvine Lennar
Irvine 5359777, California 5332921 92618
Contact:
Ria Ronquillo
949-671-4056
rironquillo@coh.org

Cancer & Blood Specialty Clinic
Lakewood 5364855, California 5332921 90712
Contact:
Susan Tieng
stieng@cbsclinic.com

USC Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90089
Contact:
Charlean Ketchens
323-226-8326
ketchens_c@med.usc.edu

Sarcoma Oncology Center
Santa Monica 5393212, California 5332921 90403
Contact:
Jason Ballon
jballon@sarcomaoncology.com

Mayo Clinic - Jacksonville
Jacksonville 4160021, Florida 4155751 32224
Contact:
Robert Jones
Jones.Robert2@mayo.edu

The Winship Cancer Institute Emory University
Atlanta 4180439, Georgia 4197000 30322
Contact:
Kathleen Coleman
404-251-1278
kathleen.marie.coleman@emory.edu

Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise 5586437, Idaho 5596512 83712
Contact:
Tammie Eslinger
eslinget@slhs.org

University of Kansas Cancer Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
Jordan Rose
913-574-0015
jrose6@kumc.edu

UofL Health Brown Cancer Center
Louisville 4299276, Kentucky 6254925 40202
Contact:
Christa Baxter
502-562-4006
christa.baxter@louisville.edu

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
Contact:
Kenna Nettles
Knettles1@umc.edu

Christus St. Vincent Regional Medical Center
Santa Fe 5490263, New Mexico 5481136 87505
Contact:
Caitlyn Pallas
505-913-8937
Caitlyn.pallas@stvin.org

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10021
Contact:
Amin Yaqubie
646-888-4327
yaqubiea@mskcc.org

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
Contact:
Gabrielle Isom
gisom@montefiore.org

University of North Carolina (UNC) - Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Maggie Schiessl
Maggie_schiessl@med.unc.edu

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Adam Cruz
Adam.Cruz@UHhospitals.org

The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)
Columbus 4509177, Ohio 5165418 43210
Contact:
Carie Heflin
614-366-3822
carie.heflin@osumc.edu

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Debbie Diecks
412-623-8364
diecksda@upmc.edu

Prisma Health Cancer Institute
Greenville 4580543, South Carolina 4597040 29605
Contact:
Kim Williams
864-241-7272
kim.williams3@prismahealth.org

Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031
Contact:
Nicole Villa
703-280-5390
Nicole.Villa@usoncology.com

Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502
Contact:
Amber Ingram
amber.ingram@usoncology.com

UW Carbone Cancer Center - Cancer Connect
Madison 5261457, Wisconsin 5279468 53706
Contact:
800-622-8922
cancerconnect@uwcarbone.wisc.edu

More Details

NCT ID
NCT06679985
Status
Recruiting
Sponsor
Coherus Oncology, Inc.

Study Contact

Clinical Operations Team
1-800-794-5434
clinicaltrials@coherus.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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