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
Recruiting now · Phase 1/Phase 2
Conditions studied: Pancreatic Ductal Adenocarcinoma
In brief
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
Key facts
- Study ID
- NCT05257993
- Run by
- Onconic Therapeutics Inc.
- People needed
- 71
- Starts
- 2022-03-30
- Expected to finish
- 2030-04-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 19 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
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
- 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
- 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
- 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
Where it is running
- Seoul National University Bundang Hospital — Gyeonggi-do, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Seoul national university hospital — Seoul, South Korea (enrolling)
- Severance Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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