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Recruiting Phase 1/2

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

NCT05257993 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 1/2
Started
2022-03-30
Last updated
2026-04-13

Condition(s) studied

Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

JPI-547 →modified FOLFIRINOX →Gemcitabine-nab-paclitaxel →

JPI-547: * Subjects are administered this investigational product once a week for 5 days, and have wash-out period for 2 days (5 Days on-2 Days off). * The investigational product is administered orally in a fasting state for 2 hours before and after meals at the same time (e.g., a certain time in the morning). * Capsules should be swallowed whole and should not be chewed, crushed or split.

modified FOLFIRINOX: * After IV administration of Oxaliplatin 65 mg/m2 for 2 hours * After IV administration of Leucovorin 400 mg/m2 for 2 hours + IV administration of Irinotecan 135 mg/m2 for 90 minutes (Irinotecan is started 30 minutes after the start of Leucovorin administration and administered simultaneously during the last 90 minutes of Leucovorin administration, but administered separately using a Y-connector without mixing) * Continuous IV infusion of 5-FU 2400 mg/m2 for 46 hours * Repeated administration every 2 weeks on a 14-day cycle

Gemcitabine-nab-paclitaxel: * After IV administration of nab-paclitaxel 125 mg/m2 for 30 minutes * IV administration of Gemcitabine 1000 mg/m2 for 30 minutes * Administration on Days 1, 8, and 15 on a 28-day cycle

Study 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

Sex
ALL
Min age
19 Years
Max age
79 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Phase 1b: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). — From the date of administration to 4 weeks (DLT period)
    The MTD is determined according to the traditional 3+3 rule-based method for each combination therapy, and it is defined as the highest dose with a DLT incidence of less than 1/3 or 2/6 subjects.
  • Phase 2: To determine the regimen of JPI-547 in combination with Chemotherapy GemAbraxane and to evaluate the potential antitumor activity and safety of the combination therapy. — From first dose until disease progression, assessed up to end of study

Trial sites (4)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Gyeonggi-do South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Seoul national university hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05257993 on ClinicalTrials.gov ↗ ← All trials in South Korea