Actively Recruiting

Phase 1
Phase 2
Age: 19Years - 75Years
All Genders
NCT07114861

The KN510713 Study in Combination With mFOLFIRINOX

Led by New Cancer Cure-Bio Co.,Ltd. · Updated on 2026-04-13

30

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is designed to evaluate the safety and efficacy of KN510713 in combination with mFOLFIRINOX in patients with locally advanced or metastatic pancreatic cancer. The study will be conducted in two parts: Part 1 (Dose-finding) and Part 2 (Dose expansion).

CONDITIONS

Official Title

The KN510713 Study in Combination With mFOLFIRINOX

Who Can Participate

Age: 19Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 to 75 years who provide written informed consent
  • Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma
  • Scheduled to receive treatment with mFOLFIRINOX
  • No prior systemic chemotherapy for locally advanced or metastatic pancreatic cancer (prior neoadjuvant or adjuvant chemotherapy allowed if no disease progression within 6 months after last dose)
  • At least one measurable lesion according to RECIST version 1.1
  • ECOG performance status of 0 or 1
  • Expected survival of at least 12 weeks
  • Adequate blood, kidney, liver, and coagulation function based on laboratory tests
  • Voluntarily signed informed consent form
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to the investigational product, combination anticancer agents, their components, or similar drugs
  • History of any malignancy other than pancreatic cancer within 5 years prior to screening, except successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ with no recurrence for over 3 years
  • Major surgery requiring general anesthesia or ventilatory support within 4 weeks prior to baseline (VATS or ONC surgery limited to 2 weeks)
  • Clinically significant arrhythmia, recent acute myocardial infarction, unstable angina, or severe heart failure within 24 weeks prior to baseline
  • Pulmonary thrombosis, deep vein thrombosis, or serious lung diseases including acute respiratory distress syndrome, lung failure, or asthma/COPD unsuitable for participation within 24 weeks
  • Known DPD deficiency
  • Known homozygous or compound heterozygous genetic polymorphisms of UGT1A16 or UGT1A128
  • Known fructose intolerance
  • Moderate or higher peripheral neuropathy (Grade 2+)
  • Chronic diarrhea or inflammatory bowel disease such as Crohn's disease or ulcerative colitis
  • Ileus or intestinal obstruction
  • Significant interstitial lung disease or pulmonary fibrosis requiring steroids
  • Chronic kidney disease requiring dialysis
  • Symptomatic or uncontrolled central nervous system or brain metastases (unless stable for 4+ weeks without steroids)
  • Uncontrolled hypertension (blood pressure ≥160/100 mmHg)
  • QTc interval >450 ms on ECG
  • Active hepatitis B or C
  • Known HIV infection
  • Conditions interfering with oral intake or drug absorption
  • History or symptoms of gastro-esophageal reflux disease, gastric or duodenal ulcers, or reflux esophagitis
  • Parkinson's disease or related movement disorders
  • Symptomatic or uncontrolled ascites or pleural effusion
  • Any serious disease or condition that may affect study results or contraindicate anticancer agents as judged by the investigator
  • Radiotherapy within 2 weeks prior to screening (exceptions for symptom relief or bone lesion treatment completed ≥1 week prior)
  • Use of proton pump inhibitors other than the investigational product within 2 weeks prior to screening
  • Use or anticipated need for antithrombotic agents within 2 weeks prior to screening (except low-molecular-weight heparin for thrombosis prophylaxis or management)
  • Use of rilpivirine- or atazanavir-containing products within 2 weeks prior to screening
  • Current or anticipated use of strong CYP3A4 or CYP2C19 inhibitors, inducers, or substrates
  • High dose methotrexate (≥1000 mg/m2)
  • Use of St. John's wort
  • Continuous use (≥4 weeks) of systemic corticosteroids equivalent to >10 mg/day prednisone (short-term and local use allowed)
  • Use or anticipated need for sorivudine
  • Pregnant or breastfeeding women, or women and men unwilling to use contraception or abstain from sexual activity for specified periods after treatment
  • Participation in another clinical trial or use of investigational drugs or devices within 4 weeks prior to screening
  • Any other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Cancer Center

Goyang-si, South Korea

Actively Recruiting

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Research Team

J

Joon Hee Kang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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The KN510713 Study in Combination With mFOLFIRINOX | DecenTrialz