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

Trial ID: NCT05257993

Interventional - Phase 1 - Recruiting

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

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

• JPI-547
• modified FOLFIRINOX
• Gemcitabine-nab-paclitaxel

Eligibility

Inclusion criteria

• 1. Histologically or cytologically confirmed inoperable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
• 2. Those with at least one measurable lesion in accordance with RECIST 1.1
• 3. Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• 4. Those with an expected survival period ≥12 weeks
• 5. 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.)
• 6. Those who voluntarily decide to participate in this clinical study after hearing sufficient explanations and who consent in writing

Exclusion criteria

• 1. Those with a history of severe hypersensitivity to the investigational product or combination anticancer drugs.
• 2. Those with the following medical history or surgical history/procedural history confirmed
• 1. Other primary malignant tumors other than pancreatic cancer
• 2. Major surgery that requires general anesthesia or breathing aid
• 3. Severe cardiovascular disease
• 4. New York Heart Association Class 3 or 4 heart failure
• 5. Severe cerebrovascular disease t
• 6. Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive pulmonary disease, and other life-threatening severe lung diseases
• 7. Infections requiring administration of systemic antibiotics or antivirals, etc.
• 8. Hematologic malignancy
• 3. Those with the following diseases
• 1. Massive ascites, pleural effusions requiring therapeutic paracentesis
• 2. Neuropathy ≥Grade 2
• 3. Diarrhea, chronic inflammatory bowel disease
• 4. Intestinal paralysis, intestinal obstruction
• 5. Diseases that make oral administration difficult or affect absorption
• 6. Interstitial lung disease, pulmonary fibrosis
• 7. Dialysis patient
• 8. 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
• 4. Those with a medication history of the following drugs
• 1. Anti-cancer drug therapy such as chemotherapy and biological therapy
• 2. Radiation therapy within 2 weeks of baseline
• 3. Those who are taking or expected to require administration of strong inhibitors or inducers of CYP3A4
• 4. (For mFOLFIRINOX cohort) Those who are taking or expected to require administration of sorivudine
• 5. Patients who require continuous administration of non-steroidal anti-inflammatory drugs (NSAIDs) with high bleeding risk
• 6. Patients requiring continuous administration of systemic corticosteroid equivalent to prednisone \>10 mg/day
• 7. Those who have received antithrombotic agents, including antiplatelet agents, anticoagulants, etc.
• 5. Pregnant women, lactating women, or women of childbearing potential and men who do not intend to practice abstinence or use appropriate contraceptive methods for until 6 months for men and 9 months for women after administration of the investigational product and during the clinical study
• 6. Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
• 7. Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator

Sponsor

Onconic Therapeutics Inc.

Source: ClinicalTrials.gov

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