Study to Assess the Safety, Tolerability of JPI-547 in Combination With Modified FOLFIRINOX or Gemcitabine-nab-paclitaxel in Patients With Locally Advanced and Metastatic Pancreatic Cancer

Inclusion criteria

• \[Phase 1b/2\]
• Histologically or cytologically confirmed inoperable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
• Those with at least one measurable lesion in accordance with RECIST 1.1
• Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Those with an expected survival period ≥12 weeks
• Patients with adequate hematologic function, renal and hepatic function confirmed by the following criteria (During the screening period, laboratory tests can be retested only once.)
• Those who voluntarily decide to participate in this clinical study after hearing sufficient explanations and who consent in writing
• \[only to Phase 2\]
• \. Subjects from whom tumor tissue samples can be obtained at screening and who meet at least one of the following criteria:
• Tumor tissue samples stored prior to screening are available
• Tumor tissue samples can be obtained at screening with the subject's consent to biopsy

Exclusion criteria

• \[Phase 1b/2\]
• Those with a history of severe hypersensitivity to the investigational product or combination anticancer drugs.
• Those with the following medical history or surgical history/procedural history confirmed
• Other primary malignant tumors other than pancreatic cancer
• Major surgery that requires general anesthesia or breathing aid
• Severe cardiovascular disease
• New York Heart Association Class 3 or 4 heart failure
• Severe cerebrovascular disease t
• Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive pulmonary disease, and other life-threatening severe lung diseases
• Infections requiring administration of systemic antibiotics or antivirals, etc.
• Hematologic malignancy
• Those with the following diseases
• Massive ascites, pleural effusions requiring therapeutic paracentesis
• Neuropathy ≥Grade 2
• Diarrhea, chronic inflammatory bowel disease
• Intestinal paralysis, intestinal obstruction
• Diseases that make oral administration difficult or affect absorption
• Interstitial lung disease, pulmonary fibrosis
• Dialysis patient
• Patients with clinically significant symptoms or uncontrolled central nervous system or brain metastases
• j. Uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \>90 mmHg) k. Bleeding diatheses l. Active hepatitis B or C virus. m. Known human immunodeficiency virus (HIV) positive
• Those with a medication history of the following drugs
• Anti-cancer drug therapy such as chemotherapy and biological therapy
• Radiation therapy within 2 weeks of baseline
• Those who are taking or expected to require administration of strong inhibitors or inducers of CYP3A4
• (For mFOLFIRINOX cohort) Those who are taking or expected to require administration of sorivudine
• Patients who require continuous administration of non-steroidal anti-inflammatory drugs (NSAIDs) with high bleeding risk
• Patients requiring continuous administration of systemic corticosteroid equivalent to prednisone \>10 mg/day
• Those who have received antithrombotic agents, including antiplatelet agents, anticoagulants, etc.
• Pregnant women, lactating women, or women of childbearing potential and men who do not intend to practice abstinence or use appropriate contraceptive methods for until 6 months for men and 9 months for women after administration of the investigational product and during the clinical study
• Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
• Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator