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
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
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
Parallel
JPI-547
Drug* 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
Drug* 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
Drug* 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
Phase 1b: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
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.
To assess the adverse events, drug adverse events, and serious adverse events evaluated by NCI-CTCAE v5.0
To evaluate anti-tumor activity.
Anti-tumor activity is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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