Study to Assess the Safety, Tolerability of JPI-547 in Co... | NCT05257993

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A (mFOLFIRINOX)	Experimental	JPI-547 and Combination Chemotherapy(mFOLFIRINOX) The study is conducted in a 3+3 dose escalation method.	Drug: JPI-547 Drug: modified FOLFIRINOX
Arm B (GemAbraxane)	Experimental	JPI-547 and Combination Chemotherapy (Gemcitabine-nab-paclitaxel) The study is conducted in a 3+3 dose escalation method.	Drug: JPI-547 Drug: Gemcitabine-nab-paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JPI-547	Drug	Subjects are administered this investigational product once a week for 5 days, and have wash-out period for 2 days (5 Days on-2 Days off). The investigational product is administered orally in a fasting state for 2 hours before and after meals at the same time (e.g., a certain time in the morning). Capsules should be swallowed whole and should not be chewed, crushed or split.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase 1b: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).	The MTD is determined according to the traditional 3+3 rule-based method for each combination therapy, and it is defined as the highest dose with a DLT incidence of less than 1/3 or 2/6 subjects.	From the date of administration to 4 weeks (DLT period)
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.		From first dose until disease progression, assessed up to end of study

Secondary Outcomes

Measure	Description	Time Frame
To assess the adverse events, drug adverse events, and serious adverse events evaluated by NCI-CTCAE v5.0		Until 4 weeks after the last dose administration
To evaluate anti-tumor activity.	Anti-tumor activity is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

[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

Exclusion Criteria:

[Phase 1b/2]

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
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
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
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.
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
Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator