Actively Recruiting
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
Led by Onconic Therapeutics Inc. · Updated on 2026-04-13
71
Participants Needed
4
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed inoperable locally advanced or metastatic pancreatic ductal adenocarcinoma
- At least one measurable lesion per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival of 12 weeks or more
- Adequate blood, kidney, and liver function confirmed by laboratory tests
- Voluntary written informed consent
- For Phase 2 only: availability of tumor tissue samples either from prior storage or biopsy at screening with consent
You will not qualify if you...
- History of severe hypersensitivity to the investigational drug or chemotherapy drugs used
- Other primary cancers besides pancreatic cancer
- Major surgery requiring general anesthesia or breathing support recently
- Severe heart disease or heart failure of NYHA class 3 or 4
- Severe stroke or cerebrovascular disease
- Serious lung diseases such as pulmonary thrombosis, asthma, COPD, or life-threatening lung conditions
- Active infections needing systemic antibiotics or antivirals
- Blood cancers
- Massive ascites or pleural effusions needing treatment
- Neuropathy grade 2 or higher
- Diarrhea or chronic inflammatory bowel disease
- Intestinal paralysis or obstruction
- Conditions interfering with oral drug intake or absorption
- Interstitial lung disease or pulmonary fibrosis
- Dialysis
- Uncontrolled central nervous system or brain metastases
- Uncontrolled high blood pressure
- Bleeding disorders
- Active hepatitis B or C virus infection
- Known HIV infection
- Recent chemotherapy, biological therapy, or radiation therapy within 2 weeks
- Use or expected need for strong CYP3A4 inhibitors/inducers or sorivudine (for mFOLFIRINOX group)
- Continuous use of high-risk NSAIDs or corticosteroids above prednisone 10 mg/day
- Use of antithrombotic medications
- Pregnant or breastfeeding women or those not using adequate contraception
- Use of other investigational products or devices within 4 weeks
- Any condition making participation unsafe or inappropriate at investigator's discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
3
Seoul national university hospital
Seoul, South Korea
Actively Recruiting
4
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
O
OnconicTherapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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