A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Intravenously Administered Nerofe™ in Subjects With Advanced Malignancies
This is a Phase 1 single-center, open-label, non-randomized, dose-escalation study, to be
conducted in 2 phases. The Dose Escalation Phase will determine the maximum tolerated dose
(MTD) of Nerofe and evaluate its safety and tolerability, pharmacokinetics,
pharmacodynamics, immunogenicity, and preliminary clinical effects. The subsequent Dose
Confirmation Phase will be a cohort expansion at or below the MTD of Nerofe. Subjects will
be treated with IV doses of Nerofe thrice weekly (on alternating days) in consecutive,
28-day cycles. Subjects will be evaluated regularly for safety. Subjects who tolerate the
drug and who do not experience progressive disease, intolerable toxicity, or meet any of the
other withdrawal criteria may continue to receive Nerofe for up to 6 cycles, at the
discretion of the Principal Investigator. Throughout the trial, oversight will be provided
by the Clinical Safety Committee.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety, as determined by frequency, nature, and severity of adverse events; and the profile of dose-limiting toxicities
Up to 6 months
Yes
Yoram Devary, PhD
Study Director
Immune System Key Ltd
Israel: Ministry of Health
ISK-N101
NCT01690741
April 2013
October 2014
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