Last updated on August 2019

Study of a New Intravenous Drug Called S65487 in Patients With Acute Myeloid Leukemia Non Hodgkin Lymphoma or Multiple Myeloma

Brief description of study

The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL) or Multiple Myeloma (MM).

Detailed Study Description

This study is designed in two parts: one part for dose escalation, one part for dose expansion.The dose escalation part will be followed by expansion part at the MTD(s)/RP2D(s)

This study will utilize a Bayesian Hierarchical model to guide dose escalation and estimate the MTD(s) based on the Dose Limiting Toxicity (DLT) relationship(s) for S65487 in the indications.

Clinical Study Identifier: NCT03755154

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