Advanced Solid Tumors Clinical Trial
Official title:
A Phase I Study of NK012 in Combination With Carboplatin in Patients With Advanced Solid Tumors Followed by a Dose Expansion Phase in Patients With Triple Negative Metastatic Breast Cancer
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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