The KN510713 Study in Combination With mFOLFIRINOX (NCT07114861) | Clinical Trial Compass
RecruitingPhase 1/2
The KN510713 Study in Combination With mFOLFIRINOX
South Korea30 participantsStarted 2025-12-16
Plain-language summary
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).
Who can participate
Age range19 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult male and female subjects aged 19 to 75 years at the time of providing written informed consent
✓. Subjects with histologically or cytologically confirmed unresectable, locally advanced or metastatic PDAC who are scheduled to receive treatement with mFOLFIRINOX
✓. 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)
✓. Subjects with at least one measurable lesion according to RECIST ver1.1
✓. Subjects with an ECOG performance status of 0 or 1
✓. Subjects with an expected survival of at least 12 weeks
✓. 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)
✓. Subjects who have been informed about the clinical study and voluntarily signed the written informed consent form
Exclusion criteria
✕. 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).
What they're measuring
1
Number of occurrences, affected subjects with adverse events.
Timeframe: Through study completion, an average of 12 months
2
The frequency and percentage of Dose-Limiting Toxicitys
. 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 for study participation, occurring within 24 weeks prior to baseline.
✕. Known DPD deficiency
✕. 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)
✕. Known fructose intolerance 3) Comorbidities or conditions as follows:
✕. 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)