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 | Recruiting Phase 1

• 1 other identifier: JPI-547-102
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 4

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

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  From the date of administration to 4 weeks (DLT period)

• 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

Secondary Outcomes (2)

• To assess the adverse events, drug adverse events, and serious adverse events evaluated by NCI-CTCAE v5.0

  Until 4 weeks after the last dose administration

• To evaluate anti-tumor activity.

  Evaluation at 8 weeks intervals through study completion from the date of study entry until the date of progression, up to 18 months

Study Arms (2)

Arm A (mFOLFIRINOX)

EXPERIMENTAL

JPI-547 and Combination Chemotherapy(mFOLFIRINOX) The study is conducted in a 3+3 dose escalation method.

Drug: JPI-547; Drug: modified FOLFIRINOX

Arm B (GemAbraxane)

EXPERIMENTAL

JPI-547 and Combination Chemotherapy (Gemcitabine-nab-paclitaxel) The study is conducted in a 3+3 dose escalation method.

Drug: JPI-547; Drug: Gemcitabine-nab-paclitaxel

Interventions

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.

Arm A (mFOLFIRINOX); Arm B (GemAbraxane)

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

Arm A (mFOLFIRINOX)

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

Arm B (GemAbraxane)

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Phase 1b/2\]
• 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
• 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.)
• Those who voluntarily decide to participate in this clinical study after hearing sufficient explanations and who consent in writing
• \[only to Phase 2\]
• \. 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

You may not qualify if:

• \[Phase 1b/2\]
• 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
• Severe cardiovascular disease
• New York Heart Association Class 3 or 4 heart failure
• Severe cerebrovascular disease t
• Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive pulmonary disease, and other life-threatening severe lung diseases
• Infections requiring administration of systemic antibiotics or antivirals, etc.
• Hematologic malignancy
• Those with the following diseases
• Massive ascites, pleural effusions requiring therapeutic paracentesis
• Neuropathy ≥Grade 2
• Diarrhea, chronic inflammatory bowel disease

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (4)

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

Central Study Contacts

OnconicTherapeutics

CONTACT

82-2-3454-0780; onconictherapeutics@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 25, 2022
• Study Start: March 30, 2022
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

KR (4)