This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed after first-line therapy.
Histologically or cytologically confirmed locally advanced or metastatic PDAC, progressed after only one prior line of systemic therapy.
At least one measurable lesion per RECIST v1.1.
ECOG Performance Status of 0-1.
Life expectancy >3 months.
Known hypersensitivity to MR001 or similar monoclonal antibodies.
Requirement for systemic immunosuppressive therapy within 14 days before first dosing.
Uncontrolled active infections or concurrent malignancies.
Not adequately controlled active brain metastases or leptomeningeal metastasis.
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Treatment groupsSee each treatment group below.