An Open-label, Dose-finding, Phase Ib 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

Who is this study for? Patients with Pancreatic Ductal Adenocarcinoma
What treatments are being studied? JPI-547
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to assess the safety, tolerability of JPI-547 in combination with modified FOLFIRINOX (mFOLFIRINOX) or Gemcitabine-nab-paclitaxel (GemAbraxne) in patients with locally advanced and metastatic pancreatic cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 79
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Gyeonggi-do
Samsung Medical Center
RECRUITING
Seoul
Seoul national university hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
OnconicTherapeutics
onconictherapeutics@gmail.com
82-2-3454-0780
Time Frame
Start Date: 2022-03-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 30
Treatments
Experimental: Arm A (mFOLFIRINOX)
JPI-547 and Combination Chemotherapy(mFOLFIRINOX) The study is conducted in a 3+3 dose escalation method.
Experimental: Arm B (GemAbraxane)
JPI-547 and Combination Chemotherapy (Gemcitabine-nab-paclitaxel) The study is conducted in a 3+3 dose escalation method.
Related Therapeutic Areas
Sponsors
Leads: Onconic Therapeutics Inc.

This content was sourced from clinicaltrials.gov

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