Study to Assess the Safety, Tolerability of JPI-547 in Combination With Modified FOLFIRINOX or Ge… (NCT05257993) | Clinical Trial Compass
RecruitingPhase 1/2
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
South Korea71 participantsStarted 2022-03-30
Plain-language 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
Who can participate
Age range19 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Phase 1b: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Timeframe: From the date of administration to 4 weeks (DLT period)
2
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.
Timeframe: From first dose until disease progression, assessed up to end of study