A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma

NCT ID: NCT06679985

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab

Group Type EXPERIMENTAL

Casdozokitug

Intervention Type DRUG

Solution for infusion

Toripalimab

Intervention Type DRUG

Solution for infusion

Bevacizumab

Intervention Type DRUG

Solution for infusion

Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab

Group Type EXPERIMENTAL

Casdozokitug

Intervention Type DRUG

Solution for infusion

Toripalimab

Intervention Type DRUG

Solution for infusion

Bevacizumab

Intervention Type DRUG

Solution for infusion

Arm C: Toripalimab + Bevacizumab

Group Type ACTIVE_COMPARATOR

Toripalimab

Intervention Type DRUG

Solution for infusion

Bevacizumab

Intervention Type DRUG

Solution for infusion

Interventions

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Casdozokitug

Solution for infusion

Intervention Type DRUG

Toripalimab

Solution for infusion

Intervention Type DRUG

Bevacizumab

Solution for infusion

Intervention Type DRUG

Other Intervention Names

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CHS-388

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coherus Oncology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Winship Cancer Institute Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Mayo Clinic - Scottsdale

Scottsdale, Arizona, United States

Site Status RECRUITING

University of Arizona - Cancer Center

Tucson, Arizona, United States

Site Status RECRUITING

Beverly Hills Cancer Center

Beverly Hills, California, United States

Site Status RECRUITING

City of Hope

Duarte, California, United States

Site Status RECRUITING

City of Hope at Irvine Lennar

Irvine, California, United States

Site Status RECRUITING

Cancer & Blood Specialty Clinic

Lakewood, California, United States

Site Status RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Sarcoma Oncology Center

Santa Monica, California, United States

Site Status RECRUITING

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

Site Status RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status RECRUITING

UofL Health Brown Cancer Center

Louisville, Kentucky, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Christus St. Vincent Regional Medical Center

Santa Fe, New Mexico, United States

Site Status RECRUITING

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

University of North Carolina (UNC) - Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

Columbus, Ohio, United States

Site Status RECRUITING

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Prisma Health Cancer Institute

Greenville, South Carolina, United States

Site Status RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status RECRUITING

UW Carbone Cancer Center - Cancer Connect

Madison, Wisconsin, United States

Site Status RECRUITING

Royal Brisbane and Women's Hospital

Herston, Brisbane, Australia

Site Status RECRUITING

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

Site Status RECRUITING

Monash Health

Melbourne, Victoria, Australia

Site Status RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, , Australia

Site Status RECRUITING

Linear Clinical Research

Nedlands, , Australia

Site Status RECRUITING

Sunnybrook Health Sciences Centre - Bayview Campus

Toronto, Ontario, Canada

Site Status RECRUITING

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

Site Status RECRUITING

Humanity & Health Clinical Trial Centre

Hong Kong, , Hong Kong

Site Status RECRUITING

National Cancer Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Curie Oncology

Singapore, , Singapore

Site Status RECRUITING

China Medical University Hospital

Taichung, Taichung City, Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital

Tainan, Tainan City, Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Tainan, Taipei City, Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, Taipei City, Taiwan

Site Status RECRUITING

Chi Mei Medical Center

Tainan, , Taiwan

Site Status RECRUITING

Linkou Chang Gung Memorial Hospital (CGMHLK)

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

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United States Australia Canada Hong Kong Singapore Taiwan

Central Contacts

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Clinical Operations Team

Role: CONTACT

1-800-794-5434

Facility Contacts

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Jose Silva

Role: primary

480-342-5083

Prisca Zimmerman

Role: primary

Diana Amaya

Role: primary

310-432-8900

Steven Carrasco

Role: primary

Ria Ronquillo

Role: backup

Ria Ronquillo

Role: primary

949-671-4056

Susan Tieng

Role: primary

Role: backup

Charlean Ketchens

Role: primary

323-226-8326

Jason Ballon

Role: primary

Robert Jones

Role: primary

Kathleen Coleman

Role: primary

404-251-1278

Tammie Eslinger

Role: primary

Jordan Rose

Role: primary

913-574-0015

Christa Baxter

Role: primary

502-562-4006

Kenna Nettles

Role: primary

Caitlyn Pallas

Role: primary

505-913-8937

Amin Yaqubie

Role: primary

646-888-4327

Gabrielle Isom

Role: primary

Maggie Schiessl

Role: primary

Adam Cruz

Role: primary

Carie Heflin

Role: primary

614-366-3822

Debbie Diecks

Role: primary

412-623-8364

Kim Williams

Role: primary

864-241-7272

Nicole Villa

Role: primary

703-280-5390

Amber Ingram

Role: primary

Role: primary

800-622-8922

Michelle Cybulski

Role: primary

+61 7 3647 0677

Mafizul Hoque

Role: primary

+61 2 9722 8622

Danica Suarez-Borinaga

Role: primary

61385722571

Ashley Douglas

Role: primary

02 9355 5613

Jessica Terrill

Role: primary

+61 1300 546 327

Role: backup

Noelle Crasto

Role: primary

Meshanthini Rabindranath

Role: primary

Nicole Yim

Role: primary

85235051046

Christie Li

Role: primary

+852 22551661

Ivy Wong

Role: primary

+852-21169283

Xiao Han Ho

Role: primary

(65) 8619 7681

Chen Hui Yang

Role: primary

+65 8905 0682

Hui Shan Chong

Role: primary

+65 9829 7005

Yi-Ting Lin

Role: primary

0972-980361

Ting-Ting Yang

Role: primary

+886-6-2353535 ext. 3589

Ya-Wen Tai

Role: primary

Pei-Yu Lai

Role: primary

886 2 2871-2121 ext. #2017

Pei-Yu Lai

Role: backup

Jennie Hsieh

Role: primary

0972-090776

Hsing-Hsun (Sissi) Chang

Role: primary

+886-936-709-438

Other Identifiers

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CHS-388-202

Identifier Type: -

Identifier Source: org_study_id

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