Pancreatic Ductal AdenocarcinomaPhase 1/2NCT05257993
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
A Phase 1/2 study testing JPI-547, modified FOLFIRINOX and Gemcitabine-nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Onconic Therapeutics Inc. at 4 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- JPI-547, modified FOLFIRINOX and Gemcitabine-nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 30 Mar 2022to Apr 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [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.)
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- Those who voluntarily decide to participate in this clinical study after hearing sufficient explanations and who consent in writing
- [only to Phase 2]
- 1. 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
Who cannot join
- [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
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- 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
- Intestinal paralysis, intestinal obstruction
- Diseases that make oral administration difficult or affect absorption
- Interstitial lung disease, pulmonary fibrosis
- Dialysis patient
- Patients with clinically significant symptoms or uncontrolled central nervous system or brain metastases
- 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
- Those with a medication history of the following drugs
- Anti-cancer drug therapy such as chemotherapy and biological therapy
- Radiation therapy within 2 weeks of baseline
- Those who are taking or expected to require administration of strong inhibitors or inducers of CYP3A4
- (For mFOLFIRINOX cohort) Those who are taking or expected to require administration of sorivudine
- Patients who require continuous administration of non-steroidal anti-inflammatory drugs (NSAIDs) with high bleeding risk
- Patients requiring continuous administration of systemic corticosteroid equivalent to prednisone >10 mg/day
- Those who have received antithrombotic agents, including antiplatelet agents, anticoagulants, etc.
- 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
- Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
- Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do
JW Kim
- Recruiting
Samsung Medical Center
Seoul
JO Pack
- Recruiting
Seoul national university hospital
Seoul
dy Oh
- Recruiting
Severance Hospital
Seoul
HJ Choi
About this study
Official title: 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
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
Read the 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
- Being tested
- JPI-547, modified FOLFIRINOX, Gemcitabine-nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPI-547Drug
- 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 FOLFIRINOXDrug
- 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
Gemcitabine-nab-paclitaxelDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Arm A (mFOLFIRINOX) | Experimental | JPI-547 and Combination Chemotherapy(mFOLFIRINOX) The study is conducted in a 3+3 dose escalation method. Receives: 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. Receives: Drug: JPI-547; Drug: Gemcitabine-nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Until 4 weeks after the last dose administration
To evaluate anti-tumor activity.
Anti-tumor activity is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Evaluation at 8 weeks intervals through study completion from the date of study entry until the date of progression, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start30 Mar 2022
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257993
- Sponsor's protocol ID
- JPI-547-102
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05257993
- Acronym / sponsor ID
- JPI-547-102
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (mFOLFIRINOX) | Experimental | Drug: JPI-547, Drug: modified FOLFIRINOXJPI-547 and Combination Chemotherapy(mFOLFIRINOX) The study is conducted in a 3+3 dose escalation method. |
| Arm B (GemAbraxane) | Experimental | Drug: JPI-547, Drug: Gemcitabine-nab-paclitaxelJPI-547 and Combination Chemotherapy (Gemcitabine-nab-paclitaxel) The study is conducted in a 3+3 dose escalation method. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- [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
Key exclusion criteria (32 listed)
- [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
- Those with the following diseases
- Those with a medication history of the following drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arm A (mFOLFIRINOX), Arm B (GemAbraxane) |
| 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 | Arm A (mFOLFIRINOX) |
| 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 | Drug | Arm B (GemAbraxane) |
Primary outcome
Phase 1b: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Time frame: From the date of administration to 4 weeks (DLT period)
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.
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.
Time frame: From first dose until disease progression, assessed up to end of study
2 secondary outcomes
To assess the adverse events, drug adverse events, and serious adverse events evaluated by NCI-CTCAE v5.0
Time frame: Until 4 weeks after the last dose administration
To evaluate anti-tumor activity.
Time frame: Evaluation at 8 weeks intervals through study completion from the date of study entry until the date of progression, up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JPI-547, modified FOLFIRINOX and Gemcitabine-nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Onconic Therapeutics Inc. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OnconicTherapeutics (82-2-3454-0780, onconictherapeutics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). (time frame: From the date of administration to 4 weeks (DLT period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.