The primary objective is to determine the maximum tolerated dose/recommended phase II dose of the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.
NK012 will be administered as a 30 minute IV infusion, followed by a 30 minute carboplatin IV infusion. Both drugs will be administered once every 28 days. Treatment is expected to continue for 6 cycles, unless disease progression or the development of unacceptable toxicity requires discontinuation of the drug. At the discretion of the investigator, patients who show signs of benefit may continue beyond 6 cycles. Once a MTD/RD has been determined, a dose expansion cohort of patients with metastatic triple negative breast cancer will be treated at the determined MTD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
NK012 and carboplatin via infusion once every 28 days
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Number of patients with dose-limiting toxicity as determinant of the maximum tolerated dose/recommended dose
Time frame: From date of first dose to off-study (or 30 days since last dose)
Number of patients with adverse events as a measure of safety and tolerability
Time frame: From date of first dose to off-study (or 30 days since last dose)
Tumor measurements, as a measure of efficacy
Efficacy, based on RECIST 1.1, will be assessed in all solid tumors, and in a specific subset of patients with breast cancer
Time frame: Baseline, then on average every 2 months until off-study
Peak Plasma Concentration (Cmax) of NK012 and carboplatin
Time frame: 15,30,60min,1,6,24,48,50,72hrs,1,2,3,4wk
Area under the plasma concentration versus time curve (AUC) of NK012 and carboplatin
Time frame: 15,30,60min,1,6,24,48,50,72hrs,1,2,3,4wk
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