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

NCT ID: NCT05257993

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2026-06-30

Brief Summary

The purpose of this study is to assess the safety, tolerability 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A (mFOLFIRINOX)

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

Group Type: EXPERIMENTAL

JPI-547

Intervention Type: 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

Intervention Type: 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 B (GemAbraxane)

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

Group Type: EXPERIMENTAL

JPI-547

Intervention Type: 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.

Gemcitabine-nab-paclitaxel

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onconic Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Seoul national university hospital

Seoul, , South Korea

Site Status: RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

OnconicTherapeutics

Role: CONTACT

onconictherapeutics@gmail.com

82-2-3454-0780

Facility Contacts

JW Kim

Role: primary

JO Pack

Role: primary

dy Oh

Role: primary

HJ Choi

Role: primary

Other Identifiers

JPI-547-102

Identifier Type: -

Identifier Source: org_study_id