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

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 30, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2026

Conditions
Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

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."

DRUG

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"

DRUG

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"

Trial Locations (4)

Unknown

RECRUITING

Seoul National University Bundang Hospital, Gyeonggi-do

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul national university hospital, Seoul

RECRUITING

Severance Hospital, Seoul

Sponsors
All Listed Sponsors
lead

Onconic Therapeutics Inc.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter