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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

The KN510713 Study in Combination With mFOLFIRINOX

An Open-label, Dose-finding and Dose-expansion, Phase I/IIa Clinical Trial to Evaluate the Safety and Efficacy of KN510713 in Combination With mFOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Cancer

The KN510713 Study in Combination With mFOLFIRINOX (NCT07114861) is a Phase 1 / Phase 2 interventional studying Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by New Cancer Cure-Bio Co.,Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adult male and female subjects aged 19 to 75 years at the time of providing written willing to sign a consent form 2. Subjects with diagnosed by tissue sample (biopsy-confirmed) unresectable, locally advanced or metastatic PDAC who are scheduled to receive treatement with mFOLFIRINOX 3. Subjects who have not received prior systemic chemotherapy for locally advanced or metastatic pancreatic cancer (Note: Prior neo-adjuvant or adjuvant systemic chemotherapy is allowed if there was no disease progression within 6 months after the last dose of chemotherapy) 4. Subjects with at least one measurable lesion according to RECIST ver1.1 5. Subjects with an You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 6. Subjects with an expected survival of at least 12 weeks 7. Subjects with adequate hematologic function, renal and hepatic function, and coagulation function based on the following laboratory criteria (only one repeat of laboratory tests is permitted during the screening period) 8. Subjects who have been informed about the clinical study and voluntarily signed the written willing to sign a consent form form Who Should NOT Join This Trial: 1\) Known hypersensitivity to the IP, combination anticancer agents, their components, or drugs of a similar class 2) Subjects with any of the following medical history, or surgical/procedural history identified: 1. History of any malignancy other than pancreatic cancer within 5 years prior to screening (Subjects with a history of basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ at other sites may be eligible if the cancer was successfully treated and there has been no recurrence for more than 3 years, as determined by the investigator). 2. Major surgery requiring general anesthesia or ventilatory support within 4 weeks prior to baseline (Video-assisted thoracoscopic surgery (VATS) or ONC surgery is limited to 2 weeks). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adult male and female subjects aged 19 to 75 years at the time of providing written informed consent 2. Subjects with histologically or cytologically confirmed unresectable, locally advanced or metastatic PDAC who are scheduled to receive treatement with mFOLFIRINOX 3. Subjects who have not received prior systemic chemotherapy for locally advanced or metastatic pancreatic cancer (Note: Prior neo-adjuvant or adjuvant systemic chemotherapy is allowed if there was no disease progression within 6 months after the last dose of chemotherapy) 4. Subjects with at least one measurable lesion according to RECIST ver1.1 5. Subjects with an ECOG performance status of 0 or 1 6. Subjects with an expected survival of at least 12 weeks 7. Subjects with adequate hematologic function, renal and hepatic function, and coagulation function based on the following laboratory criteria (only one repeat of laboratory tests is permitted during the screening period) 8. Subjects who have been informed about the clinical study and voluntarily signed the written informed consent form Exclusion Criteria: 1\) Known hypersensitivity to the IP, combination anticancer agents, their components, or drugs of a similar class 2) Subjects with any of the following medical history, or surgical/procedural history identified: 1. History of any malignancy other than pancreatic cancer within 5 years prior to screening (Subjects with a history of basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ at other sites may be eligible if the cancer was successfully treated and there has been no recurrence for more than 3 years, as determined by the investigator). 2. Major surgery requiring general anesthesia or ventilatory support within 4 weeks prior to baseline (Video-assisted thoracoscopic surgery (VATS) or ONC surgery is limited to 2 weeks). 3. Clinically significant arrhythmia, acute myocardial infarction, unstable angina, or NYHA class III or IV heart failure within 24 weeks prior to baseline. 4. Pulmonary thrombosis, deep vein thrombosis, or other serious, life-threatening pulmonary diseases (e.g., acute respiratory distress syndrome, lung failure), or conditions such as asthma or COPD considered inappropriate for study participation, occurring within 24 weeks prior to baseline. 5. Known DPD deficiency 6. Subjects known to carry the genetic polymorphism of UGT1A1\*6 or UGT1A1\*28 as homozygotes (UGT1A1\*6/\*6 or UGT1A1\*28/\*28) or as compound heterozygotes (UGT1A1\*6/\*28) 7. Known fructose intolerance 3) Comorbidities or conditions as follows: (1) Peripheral neuropathy of moderate (Grade 2) or higher (2) Chronic diarrhea or inflammatory bowel disease (Crohn's disease, ulcerative colitis) (3) Ileus or Intestinal obstruction (4) Clinically significant symptoms of ILD or pulmonary fibrosis requiring steroid therapy (5) Chronic kidney disease requiring dialysis (6) Clinically significant symptomatic or uncontrolled central nervous system or brain metastases (permitted if systemic corticosteroids were discontinued ≥4 weeks prior to baseline and the metastases have remained stable for ≥4 weeks) (7) Uncontrolled hypertension (SBP/DBP ≥160/100 mmHg) (8) QTc \>450 ms on ECG (9) Active hepatitis B or hepatitis C (10) Known HIV infection (11) Conditions interfering with oral intake (e.g., dysphagia) or absorption (e.g., celiac disease, Crohn's disease, or a clinically significant bowel resection that may affect drug absorption) (12) Subjects with a history or suspected symptoms of gastro-esophageal reflux disease (GERD), including gastric ulcer, duodenal ulcer, or reflux esophagitis (13) Parkinson's disease, parkinsonism, tremor, restless leg syndrome, or other related movement disorders (14) Clinically significant symptomatic or uncontrolled ascites or pleural effusion (15) Subjects who, in the investigator's judgment, have a disease or condition sufficiently serious to influence the study results, or for whom the concomitant anticancer agents are contraindicated 4) Prior medications or treatments as follows: 1. Radiotherapy within 2 weeks prior to screening (radiotherapy for symptom relief or bone lesions at high risk of pathological fracture is allowed if completed ≥1 week before the planned enrollment, provided that the treated lesions is not selected as target lesions for RECIST evaluation) 2. Use of PPIs other than the IP within 2 weeks prior to screening 3. Administration of any antithrombotic agents, including antiplatelet or anticoagulant drugs, within 2 weeks prior to screening, or an anticipated need for such medication during the study period (the use of low-molecular-weight heparin \[LMWH\] for prophylaxis or management of venous thrombosis is permitted during the study) 4. Use of rilpivirine-containing products within 2 weeks prior to screening 5. Use of atazanavir-containing products within 2 weeks prior to screening 6. Current administration of, or anticipated need for strong CYP3A4 inhibitors or inducers 7. Current administration of, or anticipated need for CYP2C19 substrates, strong inhibitors, or inducers 8. High dose methotrexate (≥1000 mg/m2) 9. St. John's wort 10. Requirement for continuous use (≥4 weeks) of systemic corticosteroids equivalent to \>10 mg/day prednisone (local administration such as intra-articular, intranasal, ophthalmic, or inhaled corticosteroids, and short-term use for the treatment or prophylaxis of contrast-media allergy or AEs \[e.g., vomiting\] are permitted) 11. Current administration of, or anticipated need for sorivudine 5) Pregnant or breastfeeding women, or women of childbearing potential and men who are unwilling to remain abstinent or use appropriate contraception until 12 months (for men) or 15 months (for women) after the last administration of IP/concomitant medication following study enrollment 6) Participation in another clinical trial and administration or application of an investigational drug or device within 4 weeks prior to screening 7) Any other subject who, in the investigator's judgment, is unsuitable for participation in this study

Treatments Being Tested

DRUG

Study drug: KN510 120mg/day + KN713 90mg/day, Combination Chemotherapy: mFOLFIRINOX

KN510 120mg/day + KN713 90mg/day: once daily in 14-day (2-week) cycles. mFOLFIRINOX: Treatment is repeated every 2 weeks

DRUG

Study drug: KN510 120mg/day + KN713 120mg/day, Combination Chemotherapy: mFOLFIRINOX

KN510 120mg/day + KN713 120mg/day: once daily in 14-day (2-week) cycles. mFOLFIRINOX: Treatment is repeated every 2 weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Center
Goyang-si, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07114861), the sponsor (New Cancer Cure-Bio Co.,Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07114861 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07114861?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07114861?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07114861. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07114861. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.