The KN510713 Study in Combination With mFOLFIRINOX

ConditionLocally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age19-75

SponsorNew Cancer Cure-Bio Co.,Ltd.

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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
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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: KN510 120mg + KN713 90mgExperimental treatment 1 intervention

Group B: KN510 120mg + KN713 120mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of occurrences, affected subjects with adverse events.

Safety Evaluation(Adverse Event, Laboratory Test, Vital Signs, Electrocardiogram)

Time frame

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)

Time frame

4 weeks

Secondary outcomes

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

Time frame

Through study completion, an average of 12 months

Disease Control Rate

The proportion of subjects whose BOR is assessed as CR, PR, or stable disease (SD). DCR = CR + PR + SD

Time frame

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)

Time frame

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

Time frame

Through study completion, an average of 12 months

Other outcomes

Changes in Phospholipids

The number of subjects, mean, standard deviation, median, minimum, and maximum will be presented for changes at each time point.

Time frame

Screening, 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New Cancer Cure-Bio Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

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