Assessing JPI-547 with chemotherapy for advanced pancreatic cancer

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

This study is testing a new drug called JPI-547 combined with chemotherapy to see if it can safely help people with advanced pancreatic cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Ages: 19 Years to 79 Years
• Sex: All
• Sponsor: Onconic Therapeutics Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, Radiation, prednisone
• Locations: 4 sites (Gyeonggi-do and 3 other locations)
• Trial ID: NCT05257993 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of JPI-547 when combined with modified FOLFIRINOX or Gemcitabine-nab-paclitaxel in patients suffering from locally advanced or metastatic pancreatic ductal adenocarcinoma. The primary objectives include determining the maximum tolerated dose and the recommended phase 2 dose of the combination therapies. Secondary objectives focus on assessing safety, toxicity, and anti-tumor activity. Participants will undergo treatment and monitoring to gather data on the effectiveness and safety of these combinations.

Who should consider this trial

Good fit: Ideal candidates are individuals with inoperable locally advanced or metastatic pancreatic ductal adenocarcinoma who meet specific health criteria.

Not a fit: Patients with severe hypersensitivity to the investigational product or those with other primary malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced pancreatic cancer.

How similar studies have performed: Other studies have shown promise in combining chemotherapy with novel agents for pancreatic cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

\[Phase 1b/2\]

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

\[only to Phase 2\]

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

Exclusion Criteria:

\[Phase 1b/2\]

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

Where this trial is running

Gyeonggi-do and 3 other locations

• Seoul National University Bundang Hospital — Gyeonggi-do, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• Seoul national university hospital — Seoul, South Korea (Recruiting)
• Severance Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: OnconicTherapeutics

Conditions Pancreatic Ductal Adenocarcinoma