The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants with adverse events (AEs)
Phase 1
Time frame: Up to approximately 25 weeks
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Phase 1
Time frame: Up to approximately 25 weeks
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Phase 1
Time frame: Up to day 21
Number of participants with AEs leading to discontinuation
Phase 1
Time frame: Up to approximately 25 weeks
Number of participants with AEs leading to death
Phase 1
Time frame: Up to approximately 25 weeks
Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Phase 2
Time frame: Up to week 48
Number of participants with AEs
Phase 2
Time frame: Up to approximately 25 weeks
Number of participants with SAEs (as per CTCAE v5)
Phase 2
Time frame: Up to approximately 25 weeks
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CONTACT
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CONTACT
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Specified dose on specified days
Local Institution - 0070
Los Angeles, California, United States
Local Institution - 0107
Chicago, Illinois, United States
Local Institution - 0103
Hackensack, New Jersey, United States
Local Institution - 0100
Great Neck, New York, United States
Local Institution - 0080
Portland, Oregon, United States
Local Institution - 0022
Nashville, Tennessee, United States
Local Institution - 0102
Nashville, Tennessee, United States
Local Institution - 0083
Seattle, Washington, United States
Local Institution - 0040
Birtinya, Queensland, Australia
Local Institution - 0024
Camperdown, Australia
...and 36 more locations
Number of participants with treatment-related adverse events (TRAEs)
Phase 2
Time frame: Up to approximately 25 weeks
Number of participants with AEs leading to discontinuation
Phase 2
Time frame: Up to approximately 25 weeks
Number of participants with AEs leading to death
Phase 2
Time frame: Up to approximately 25 weeks
End of infusion concentration of Pumitamig
Phase 2
Time frame: Up to day 21
End of trough concentration of Pumitamig
Phase 2
Time frame: Up to day 21
Trough concentration of Ipilimumab
Phase 2
Time frame: Up to day 21
Incidence of anti-drug antibodies against Pumitamig
Phase 2
Time frame: Up to 5 years
Incidence of anti-drug antibodies against Ipilimumab
Phase 2
Time frame: Up to 5 years
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 4 years
Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment
Phase 2
Time frame: Up to 4 years