An Open-label, Dose-finding and Dose-expansion, Phase I/IIa Clinical Trial to Evaluate the Safety and Efficacy of KN510713 in Combination With mFOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study is designed to evaluate the safety and efficacy of KN510713 in combination with mFOLFIRINOX in patients with locally advanced or metastatic pancreatic cancer. The study will be conducted in two parts: Part 1 (Dose-finding) and Part 2 (Dose expansion).
• Adult male and female subjects aged 19 to 75 years at the time of providing written informed consent
• Subjects with histologically or cytologically confirmed unresectable, locally advanced or metastatic PDAC who are scheduled to receive treatement with mFOLFIRINOX
• Subjects who have not received prior systemic chemotherapy for locally advanced or metastatic pancreatic cancer (Note: Prior neo-adjuvant or adjuvant systemic chemotherapy is allowed if there was no disease progression within 6 months after the last dose of chemotherapy)
• Subjects with at least one measurable lesion according to RECIST ver1.1
• Subjects with an ECOG performance status of 0 or 1
• Subjects with an expected survival of at least 12 weeks
• Subjects with adequate hematologic function, renal and hepatic function, and coagulation function based on the following laboratory criteria (only one repeat of laboratory tests is permitted during the screening period)
• Subjects who have been informed about the clinical study and voluntarily signed the written informed consent form