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

Prior treatment

• Those with a history of severe hypersensitivity to the investigational product or combination anticancer drugs.
• 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 illness

• 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
  • 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

Other

• \[Phase 1b/2\]
• Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator

• \[Phase 1b/2\]
• 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
  • \[only to Phase 2\]
  • 1\. 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