This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
Able and willing to provide a written informed consent
Age 18-75 years old (inclusive) at the time of signing the informed consent form
Male or female
ECOG score of 0 or 1
Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study
Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures
Known hypersensitivity to any component of HRS-4642; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination
Received other major surgery other than diagnosis or biopsy within 28 days before the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; Presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures
Parallel
HRS-4642 + AG
DrugHRS-4642 + AG
HRS-4642 placebo + AG
DrugHRS-4642 placebo + AG
PFS as assessed by BICR per RECIST 1.1
OS
ORR,as assessed by BICR per RECIST v1.1
DCR as assessed by BICR per RECIST v1.1
DoR as assessed by BICR per RECIST v1.1
PFS as assessed by the investigator per RECIST v1.1.
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