A PHASE 1/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY OF NKTR-214 IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
The goal of this clinical research study is to find the highest tolerable dose of the study drug NKTR-214 that can be given to patients with advanced or recurrent solid tumors. Researchers also want to learn if NKTR-214 can help to control the disease. There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). This is the first study using NKTR-214 in humans.
Treatment Location: N/A
Primary Objective • To evaluate the safety and tolerability, and define the MTD of NKTR-214. • To evaluate the efficacy of NKTR-214 by assessing the objective response rate (ORR) at the MTD or the dose below the MTD. Secondary Objectives • To evaluate the efficacy of NKTR-214 by assessing best overall response (BOR), progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), median time to response (MTR), and overall survival (OS). • To characterize the pharmacokinetic (PK) profile of NKTR-214 and relevant metabolites. • To assess the immunogenicity of NKTR-214. Exploratory Objectives • To assess the immunologic effect of NKTR-214 in tumor tissue on tumor-infiltrating lymphocytes (TIL). • To assess the immunologic effects of NKTR-214 in blood, including effects on cytokines, NK cells, T-cells, and other serum proteins and immune modulators.
IRB Review and Approval Date: 11/30/2015
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Phase I/Phase II
Melanoma Medical Oncology
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