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New treatment option for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Official title The KN510713 Study in Combination With mFOLFIRINOX
ClinicalTrials.gov ID: NCT07114861
What this study is testing
What is Study drug: KN510 120mg/day + KN713 90mg/day, Combination Chemotherapy: mFOLFIRINOX?
Study drug: KN510 120mg/day + KN713 90mg/day, Combination Chemotherapy: mFOLFIRINOX is an investigational medicine, given as an once-daily, being studied as a potential treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma (pdac).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 75
You may be able to join if
- Adult male and female people aged 19 to 75 years at the time of providing written informed consent
- people with histologically or cytologically confirmed unresectable, locally advanced or metastatic PDAC who are scheduled to receive treatement with...
- people who have not received prior systemic chemotherapy for locally advanced or metastatic pancreatic cancer (Note: Prior neo-adjuvant or adjuvant...
- people with at least one measurable lesion according to RECIST ver1.1
- people with an ECOG performance status of 0 or 1
You likely can't join if
- 1) Known hypersensitivity to the IP, combination anticancer agents, their components, or drugs of a similar class 2) people with any of the following...
- History of any malignancy other than pancreatic cancer within 5 years prior to screening (people with a history of basal cell carcinoma, squamous...
- Major surgery requiring general anesthesia or ventilatory support within 4 weeks prior to baseline (Video-assisted thoracoscopic surgery (VATS) or...
- Clinically significant arrhythmia, acute myocardial infarction, unstable angina, or NYHA class III or IV heart failure within 24 weeks prior to...
- Pulmonary thrombosis, deep vein thrombosis, or other serious, life-threatening pulmonary diseases (e.g., acute respiratory distress syndrome, lung...
- Known DPD deficiency
See the full eligibility criteria
- Adult male and female people aged 19 to 75 years at the time of providing written informed consent
- people with histologically or cytologically confirmed unresectable, locally advanced or metastatic PDAC who are scheduled to receive treatement with mFOLFIRINOX
- people 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...
- people with at least one measurable lesion according to RECIST ver1.1
- people with an ECOG performance status of 0 or 1
- people with an expected survival of at least 12 weeks
- people 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)
- people who have been informed about the clinical study and voluntarily signed the written informed consent form
- 1) Known hypersensitivity to the IP, combination anticancer agents, their components, or drugs of a similar class 2) people with any of the following medical history, or surgical/procedural history identified:
- History of any malignancy other than pancreatic cancer within 5 years prior to screening (people with a history of basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ at other...
- 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).
- Clinically significant arrhythmia, acute myocardial infarction, unstable angina, or NYHA class III or IV heart failure within 24 weeks prior to baseline.
- 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...
- Known DPD deficiency
- people 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)
- 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)...
- 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...
- Use of PPIs other than the IP within 2 weeks prior to screening
- 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...
- Use of rilpivirine-containing products within 2 weeks prior to screening
- Use of atazanavir-containing products within 2 weeks prior to screening
- Current administration of, or anticipated need for strong CYP3A4 inhibitors or inducers
- Current administration of, or anticipated need for CYP2C19 substrates, strong inhibitors, or inducers
- High dose methotrexate (≥1000 mg/m2)
- St. John's wort
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Goyang-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goyang-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.