A Study to Evaluate the Efficacy and Safety of RNK08954 in Subjects With KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma
This is a multicenter, open-label, phase Ⅱa study to explore the safety, tolerability, and preliminary efficacy of RNK08954 in metastatic pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation.
• The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
• Male and female subjects aged 18-75 years (including 18 and 75 years).
• Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology.
• At the time of study enrollment, according to the solid tumor efficacy evaluation criteria (RECIST1.1), imaging diagnosis had at least one measurable lesion .
• Presence of a KRAS G12D mutation.
• Physical condition score ECOG score 0-1 points.
• Expected survival ≥ 12 weeks.
• Have adequate hematologic and end-organ function, with laboratory test results within required parameters within 7 days prior to the first dose.
• Fertile female subjects and male subjects whose partners are women of reproductive age must agree to comply with the contraceptive requirement from the time of signing the informed consent until 6 months after the final administration of the trial drug.Fertile female subjects must undergo a serum pregnancy test within 7 days before the first dose, and the result is negative; And must be non-lactating.