A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
Phase 2
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06679985
- Lead Sponsor
- Coherus Biosciences, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab Casdozokitug - Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab Casdozokitug - Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab Toripalimab - Arm A: Casdozokitug Lower Dose + Toripalimab + Bevacizumab Bevacizumab - Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab Toripalimab - Arm B: Casdozokitug Higher dose + Toripalimab + Bevacizumab Bevacizumab - Arm C: Toripalimab + Bevacizumab Toripalimab - Arm C: Toripalimab + Bevacizumab Bevacizumab -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1 Up to approximately 2 years DCR by Investigator Review According to HCC mRECIST Up to approximately 2 years Overall Survival (OS) Up to approximately 2 years Maximum Concentration (Cmax) Up to approximately 25 months Minimum Concentration (Cmin) Up to approximately 25 months Time to Cmax (Tmax) Up to approximately 25 months Duration of Response (DoR) by Investigator Review According to RECIST v1.1 Up to approximately 2 years DoR by Investigator Review According to HCC mRECIST Up to approximately 2 years Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1 Up to approximately 2 years PFS by Investigator Review According to HCC mRECIST Up to approximately 2 years ORR by Investigator Review According to HCC Modified RECIST (mRECIST) Up to approximately 2 years