Last updated on March 2019

SEL24 in Patients With AML


Brief description of study

Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML.

At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2.

In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.

Detailed Study Description

This is a Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML. At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2. In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.

Part 1 will commence with an accelerated dose escalation design for the first 4 cohorts. The study will then follow a 3+3 design from Cohort 5 onwards in order to provide adequate PK profile data. In Part 1 the MTD is defined as the highest dose at which no more than 1 in up to 6 patients experience a DLT during Cycle 1. The dose escalation rules to be followed during Part 1 of the study are described in the study protocol.

The highest SEL24 dose level considered to be well tolerated in 6 patients, and to have optimal PK and PD characteristics, will be called the RD and will be selected for further evaluation in Part 2.

Part 2 will enroll patients at the RD identified in Part 1. The treatment groups in Part 2 will be opened for recruitment based on recommendation by the Investigators, Medical Monitor and Sponsor.

Clinical Study Identifier: NCT03008187

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Recruitment Status: Open


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