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NCT Number: NCT06679985

A Trial 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brisbane and Women's Hospital, Herston, Brisbane, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Casdozokitug

Drug

Solution for infusion

Other names: CHS-388

Toripalimab

Drug

Solution for infusion

Bevacizumab

Drug

Solution for infusion

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. ORR by Investigator Review According to HCC Modified RECIST (mRECIST)

    Time frame: Up to approximately 2 years

  2. Duration of Response (DoR) by Investigator Review According to RECIST v1.1

    Time frame: Up to approximately 2 years

  3. DoR by Investigator Review According to HCC mRECIST

    Time frame: Up to approximately 2 years

  4. Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1

    Time frame: Up to approximately 2 years

  5. PFS by Investigator Review According to HCC mRECIST

    Time frame: Up to approximately 2 years

  6. Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1

    Time frame: Up to approximately 2 years

  7. DCR by Investigator Review According to HCC mRECIST

    Time frame: Up to approximately 2 years

  8. Overall Survival (OS)

    Time frame: Up to approximately 2 years

  9. Maximum Concentration (Cmax)

    Time frame: Up to approximately 25 months

  10. Minimum Concentration (Cmin)

    Time frame: Up to approximately 25 months

  11. Time to Cmax (Tmax)

    Time frame: Up to approximately 25 months

Sponsors and collaborators

Lead sponsor

Coherus Oncology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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