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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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 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

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) is a Phase 1 interventional studying Pancreatic Ductal Adenocarcinoma, sponsored by Onconic Therapeutics INC.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Pancreatic Ductal Adenocarcinoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul national university hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05257993), the sponsor (Onconic Therapeutics INC.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05257993 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05257993?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05257993?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05257993. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05257993. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.