This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
IV infusion, specified dose on specified days.
IV infusion, specified dose on specified days.
IV infusion, specified dose on specified days.
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
Wuhan, Hubei, China
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Frequency of AEs and SAEs for all Arms in phase Ib.
Time frame: 28days+28days
Overall Response Rate (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time frame: Up to approximately 2 years
Pharmacokinetics (PK)
PK parameters: serum concentrations of AK112 and Cadonilimab at different point of time
Time frame: Up to Cycle 12
Anti-Drug Antibodies(ADAs)
Number and percentage of patients with detectable anti-drug antibodies
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Evaluation of PFS based on RECIST v1.1.
Time frame: Up to approximately 2 years
Overall survival (OS)
Evaluation of OS based on RECIST v1.1.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Evaluation of DCR based on RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Evaluation of DoR based on RECIST v1.1.
Time frame: Up to approximately 2 years
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IV infusion, specified dose on specified days.
IV infusion, specified dose on specified days.
Time to Response (TTR)
Evaluation of TTR based on RECIST v1.1.
Time frame: Up to approximately 2 years