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

Coherus BioSciences

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Toripalimab; Drug: Casdozokitug; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06679985

CHS-388-202

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 3 patient groups

Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Casdozokitug

Drug: Toripalimab

Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Casdozokitug

Drug: Toripalimab

Arm C: Toripalimab + Bevacizumab

Active Comparator group

Treatment:

Drug: Bevacizumab

Drug: Toripalimab