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

An Open-label, Dose-finding, Phase Ib/II Study to Assess the Safety, Tolerability of JPI-547, a Dual Inhibitor of PARP/Tankyrase, in Combination With Modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in Patients With Locally Advanced and Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Onconic Therapeutics Inc. · Industry
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Not accepted

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

Detailed description

In combination with JPI-547 and chemotherapy in patients with locally advanced/metastatic pancreatic cancer, Primary Objectives * To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). * To select the optimal combination chemotherapy based on the safety profile. Secondary Objectives * To assess the safety and toxicity. * To evaluate anti-tumor activity.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-30
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2022-02-25
• Last updated: 2026-04-13

Locations

4 sites across 1 country: South Korea