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
‣ \[Phase 1b/2\]
⁃ 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
‣ \[only to Phase 2\]
‣ 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