Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer

Inclusion criteria

• Voluntarily participate in the study and sign the informed consent form.
• Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.
• Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.
• Have received at least one prior standard systemic therapy.
• Participants must have at least one measurable lesion (per RECIST 1.1 criteria).
• Expected survival time ≥ 12 weeks as judged by the investigator.
• Have adequate organ function

Exclusion criteria

• Other malignant tumors that progressed or required treatment within 3 years prior to randomization.
• With active central nervous system (CNS) metastasis.
• Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.
• Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.
• Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.
• With clinically significant severe cardiovascular diseases.
• Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.
• Complicated with major acute or chronic infectious diseases.
• Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.
• Pregnant or lactating females.
• Other conditions deemed inappropriate for participation in the study by the investigator.