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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KN510 120mg + KN713 90mg | Experimental |
| |
| KN510 120mg + KN713 120mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study drug: KN510 120mg/day + KN713 90mg/day, Combination Chemotherapy: mFOLFIRINOX | Drug | KN510 120mg/day + KN713 90mg/day: once daily in 14-day (2-week) cycles. mFOLFIRINOX: Treatment is repeated every 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of occurrences, affected subjects with adverse events. | Safety Evaluation(Adverse Event, Laboratory Test, Vital Signs, Electrocardiogram) | Through study completion, an average of 12 months |
| The frequency and percentage of Dose-Limiting Toxicitys | Safety/Tolerability Evaluation(Dose-Limiting Toxicity, Part 1 Subjects only) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The proportion of subjects whose best overall response (BOR) is assessed as complete response (CR) or partial response (PR). ORR = CR + PR | Through study completion, an average of 12 months |
| Disease Control Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Phospholipids | The number of subjects, mean, standard deviation, median, minimum, and maximum will be presented for changes at each time point. | Screening, 8 weeks |
Inclusion Criteria:
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) 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joon Hee Kang, Ph.D | Contact | +8231-920-2227 | wnsl2820@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang-si | South Korea |
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| Study drug: KN510 120mg/day + KN713 120mg/day, Combination Chemotherapy: mFOLFIRINOX | Drug | KN510 120mg/day + KN713 120mg/day: once daily in 14-day (2-week) cycles. mFOLFIRINOX: Treatment is repeated every 2 weeks |
|
The proportion of subjects whose BOR is assessed as CR, PR, or stable disease (SD). DCR = CR + PR + SD
| Through study completion, an average of 12 months |
| Duration of Response | The duration from the date of the first assessment of CR or PR to the date of the first assessment disease progression (PD) | Through study completion, an average of 12 months |
| Progression-Free Survival | The time from the start date of IP administration to the earlier of either PD based on RECIST ver1.1 or death from any cause | Through study completion, an average of 12 months |
| Overall Survival | The time from the start date of IP administration to the date of death from any cause | Through study completion, an average of 12 months |