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

NCT06679985 · tracked via the Priya Life Science China tracker

Sponsor

Coherus Oncology, Inc.

Phase

Phase 2

Started

2024-12-20

Last updated

2026-07-15

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

CasdozokitugToripalimabBevacizumab

Casdozokitug: Solution for infusion

Toripalimab: Solution for infusion

Bevacizumab: Solution for infusion

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants with Treatment-emergent Adverse Events (TEAEs) — 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 — Up to approximately 2 years

Trial sites (44)

Facility	City	Region
Mayo Clinic - Scottsdale	Scottsdale	Arizona
University of Arizona - Cancer Center	Tucson	Arizona
Beverly Hills Cancer Center	Beverly Hills	California
City of Hope	Duarte	California
City of Hope at Irvine Lennar	Irvine	California
Cancer & Blood Specialty Clinic	Lakewood	California
USC Norris Comprehensive Cancer Center	Los Angeles	California
Sarcoma Oncology Center	Santa Monica	California
Mayo Clinic - Jacksonville	Jacksonville	Florida
The Winship Cancer Institute Emory University	Atlanta	Georgia
Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho
University of Kansas Cancer Center	Kansas City	Kansas
UofL Health Brown Cancer Center	Louisville	Kentucky
University of Mississippi Medical Center	Jackson	Mississippi
Christus St. Vincent Regional Medical Center	Santa Fe	New Mexico
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York
Montefiore Medical Center	The Bronx	New York
University of North Carolina (UNC) - Chapel Hill	Chapel Hill	North Carolina
University Hospitals Cleveland Medical Center	Cleveland	Ohio
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)	Columbus	Ohio
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center	Pittsburgh	Pennsylvania
Prisma Health Cancer Institute	Greenville	South Carolina
Virginia Cancer Specialists	Fairfax	Virginia
Virginia Oncology Associates	Norfolk	Virginia
UW Carbone Cancer Center - Cancer Connect	Madison	Wisconsin
Royal Brisbane and Women's Hospital	Herston	Brisbane
Bankstown-Lidcombe Hospital	Bankstown	New South Wales
Monash Health	Melbourne	Victoria
St Vincent's Hospital Sydney	Darlinghurst	Australia
Linear Clinical Research	Nedlands	Australia
Sunnybrook Health Sciences Centre - Bayview Campus	Toronto	Ontario
Princess Margaret Hospital	Toronto	Ontario
Prince of Wales Hospital	Shatin	New Territories
Queen Mary Hospital	Hong Kong	Pok Fu Lam
Humanity & Health Clinical Trial Centre	Hong Kong	Hong Kong
National Cancer Centre Singapore	Singapore	Singapore
Tan Tock Seng Hospital	Singapore	Singapore
Curie Oncology	Singapore	Singapore
China Medical University Hospital	Taichung	Taichung City
National Cheng Kung University Hospital	Tainan	Tainan City

+ 4 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile →

More Coherus Oncology, Inc. trials in China

A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors Recruiting

Other trials for the same condition

The Efficacy of Sequential RT After Triple Therapy for uHCC Enrolling by invitation

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma Recruiting

Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC Recruiting

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma Recruiting

HAIC or Lenvatinib Combined With Sintilimab for High Recurrence Risk Resectable Solitary Hepatocellular Carcinoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06679985 on ClinicalTrials.gov ↗ ← All trials in China