NCT05257993 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

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 71 participants in total. It began in 2022-03-30 with a primary completion date of 2030-04.

Brief Summary

The purpose of this study is to assess the safety, tolerability and efficacy of JPI-547 in combination with modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in patients with locally advanced and metastatic pancreatic cancer

Eligibility Criteria

Inclusion Criteria: \[Phase 1b/2\] 1. Histologically or cytologically confirmed inoperable locally advanced or metastatic pancreatic 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 by the following criteria (During the screening period, laboratory tests can be retested only once.) 6. 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 Exclusion Criteria: \[Phase 1b/2\] 1. Those with a history of severe hypersensitivity to the investigational product or combination anticancer drugs. 2. Those with the following medical history or surgical history/procedural history confirmed 1. Other primary malignant tumors other than pancreatic cancer 2. Major surgery that requires general anesthesia or breathing aid 3. Severe cardiovascular disease 4. New York Heart Association Class 3 or 4 heart failure 5. Severe cerebrovascular disease t 6. Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive pulmonary disease, and other life-threatening severe lung diseases 7. Infections requiring administration of systemic antibiotics or antivirals, etc. 8. Hematologic malignancy 3. Those with the following diseases 1. Massive ascites, pleural effusions requiring therapeutic paracentesis 2. Neuropathy ≥Grade 2 3. Diarrhea, chronic inflammatory bowel disease 4. Intestinal paralysis, intestinal obstruction 5. Diseases that make oral administration difficult or affect absorption 6. Interstitial lung disease, pulmonary fibrosis 7. Dialysis patient 8. 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 4. Those with a medication history of the following drugs 1. Anti-cancer drug therapy such as chemotherapy and biological therapy 2. Radiation therapy within 2 weeks of baseline 3. Those who are taking or expected to require administration of strong inhibitors or inducers of CYP3A4 4. (For mFOLFIRINOX cohort) Those who are taking or expected to require administration of sorivudine 5. Patients who require continuous administration of non-steroidal anti-inflammatory drugs (NSAIDs) with high bleeding risk 6. Patients requiring continuous administration of systemic corticosteroid equivalent to prednisone \>10 mg/day 7. Those who have received antithrombotic agents, including antiplatelet agents, anticoagulants, etc. 5. 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 6. Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline 7. Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator

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