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Clinical Trials List

Protocol NumberCHS-388-202
NCT Number(ClinicalTrials.gov Identfier)NCT06679985
Active

2025-01-01 - 2029-12-31

Phase II

Recruiting9

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

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 郭行道 無
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shi-Ming Lin 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang 醫學研究部
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Yuan Peng Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE Digestive System Department
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曹朝榮 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

Primary Objectives • To evaluate the safety and tolerability of casdozokitug combined with toripalimab + bevacizumab • To evaluate the preliminary efficacy of casdozokitug combined with toripalimab + bevacizumab • To define the recommended dose of casdozokitug, administered intravenously every 3 weeks, in combination with toripalimab + bevacizumab

Test Drug

輸注液

Active Ingredient

Casdozokitug

Dosage Form

27C

Dosage

100mg/ 2mL, total 700 mg or 1400mg

Endpoints

• Safety was assessed based on the incidence and severity of adverse events (AEs), clinical laboratory test values, electrocardiogram (ECG), vital signs, and physical examination.

• Efficacy was assessed based on the objective response rate (ORR) as determined by the trial administrator according to the Responsive Clinical Trial Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1.

Inclution Criteria

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

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).

The Estimated Number of Participants

  • Taiwan

    9 participants

  • Global

    72 participants

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