Clinical trial NCT06679985: A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Unresectable Hepatocellular Carcinoma
Locally Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Casdozokitug
Toripalimab
Bevacizumab
HCC
Liver Cancer
IL-27
PD-1
Lead sponsor: Coherus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: From date of first dose to 90 days after date of last dose (Up to approximately 27 months)
measure: Objective Response Rate (ORR) by Investigator Review According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DoR) by Investigator Review According to RECIST v1.1
timeFrame: Up to approximately 2 years
measure: DoR by Investigator Review According to HCC mRECIST
timeFrame: Up to approximately 2 years
measure: Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1
timeFrame: Up to approximately 2 years
measure: PFS by Investigator Review According to HCC mRECIST
timeFrame: Up to approximately 2 years
measure: Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1
timeFrame: Up to approximately 2 years
measure: DCR by Investigator Review According to HCC mRECIST
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: Maximum Concentration (Cmax)
timeFrame: Up to approximately 25 months
measure: Minimum Concentration (Cmin)
timeFrame: Up to approximately 25 months
measure: Time to Cmax (Tmax)
timeFrame: Up to approximately 25 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Irvine
country: United States
facility: City of Hope at Irvine Lennar
state: California
city: Lakewood
country: United States
facility: Cancer & Blood Specialty Clinic
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Atlanta
country: United States
facility: The Winship Cancer Institute Emory University
state: Georgia
city: Boise
country: United States
facility: Mountain States Tumor Institute at St. Luke's Regional Medical Center
state: Idaho
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Santa Fe
country: United States
facility: Christus St. Vincent Regional Medical Center
state: New Mexico
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Greenville
country: United States
facility: Prisma Health Cancer Institute
state: South Carolina
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin - Carbone Cancer Center
state: Wisconsin
Study officials:
References: