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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Solution for infusion
Solution for infusion
Solution for infusion
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)
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
ORR by Investigator Review According to HCC Modified RECIST (mRECIST)
Time frame: Up to approximately 2 years
Duration of Response (DoR) by Investigator Review According to RECIST v1.1
Time frame: Up to approximately 2 years
DoR by Investigator Review According to HCC mRECIST
Time frame: Up to approximately 2 years
Progression-free Survival (PFS) by Investigator Review According to RECIST v1.1
Time frame: Up to approximately 2 years
PFS by Investigator Review According to HCC mRECIST
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) by Investigator Review According to RECIST v1.1
Time frame: Up to approximately 2 years
DCR by Investigator Review According to HCC mRECIST
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
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Scottsdale, Arizona, United States
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Irvine, California, United States
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Lakewood, California, United States
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Los Angeles, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
...and 34 more locations
Maximum Concentration (Cmax)
Time frame: Up to approximately 25 months
Minimum Concentration (Cmin)
Time frame: Up to approximately 25 months
Time to Cmax (Tmax)
Time frame: Up to approximately 25 months