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:

1. Histologically or cytologically confirmed inoperable locally advanced or metastaticpancreatic ductal adenocarcinoma (PDAC)

2. Those with at least one measurable lesion in accordance with RECIST 1.1

3. Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

4. Those with an expected survival period ≥12 weeks

5. Patients with adequate hematologic function, renal and hepatic function confirmed bythe following criteria (During the screening period, laboratory tests can beretested only once.)

6. Those who voluntarily decide to participate in this clinical study after hearingsufficient explanations and who consent in writing

Exclusion Criteria:

1. Those with a history of severe hypersensitivity to the investigational product orcombination anticancer drugs.

2. Those with the following medical history or surgical history/procedural historyconfirmed

3. Other primary malignant tumors other than pancreatic cancer

4. Major surgery that requires general anesthesia or breathing aid

5. Severe cardiovascular disease

6. New York Heart Association Class 3 or 4 heart failure

7. Severe cerebrovascular disease t

8. Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructivepulmonary disease, and other life-threatening severe lung diseases

9. Infections requiring administration of systemic antibiotics or antivirals, etc.

10. Hematologic malignancy

11. Those with the following diseases

12. Massive ascites, pleural effusions requiring therapeutic paracentesis

13. Neuropathy ≥Grade 2

14. Diarrhea, chronic inflammatory bowel disease

15. Intestinal paralysis, intestinal obstruction

16. Diseases that make oral administration difficult or affect absorption

17. Interstitial lung disease, pulmonary fibrosis

18. Dialysis patient

19. Patients with clinically significant symptoms or uncontrolled central nervoussystem or brain metastases j. Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic bloodpressure >90 mmHg) k. Bleeding diatheses l. Active hepatitis B or C virus. m. Knownhuman immunodeficiency virus (HIV) positive

20. Those with a medication history of the following drugs

21. Anti-cancer drug therapy such as chemotherapy and biological therapy

22. Radiation therapy within 2 weeks of baseline

23. Those who are taking or expected to require administration of strong inhibitorsor inducers of CYP3A4

24. (For mFOLFIRINOX cohort) Those who are taking or expected to requireadministration of sorivudine

25. Patients who require continuous administration of non-steroidalanti-inflammatory drugs (NSAIDs) with high bleeding risk

26. Patients requiring continuous administration of systemic corticosteroidequivalent to prednisone >10 mg/day

27. Those who have received antithrombotic agents, including antiplatelet agents,anticoagulants, etc.

28. Pregnant women, lactating women, or women of childbearing potential and men who donot intend to practice abstinence or use appropriate contraceptive methods for until 6 months for men and 9 months for women after administration of the investigationalproduct and during the clinical study

29. Those who have administered other investigational products or have receivedinvestigational medical device procedures within 4 weeks of the baseline

30. Other patients who are inappropriate or unable to participate in this clinical studyat the discretion of the investigator