Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia
The purpose of the clinical trial is to identify the maximum tolerated dose of SEL24/MEN1703 and to further investigate its safety profile in patients with Acute Myeloid Leukemia.
Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated dose of SEL24/MEN1703 in patients with Acute Myeloid Leukemia. The clinical trial will investigate the safety profile and anti-leukemic activity of SEL24/MEN1703 in patients with Acute Myeloid Leukemia and that have no standard therapeutic options available. The clinical trial encompasses two parts: - Part 1, ascending dose levels: the main purpose of this part of the clinical trial is to determine the highest dose of SEL24/MEN1703 considered to be well tolerated. - Part 2: Expansion cohort: the main purpose of this part of the clinical trial is to assess the safety and anti-leukemia activity of SEL24/MEN1703 given at the highest tolerated dose in patient with relapsed/refractory Acute Myeloid Leukemia, either all comers as well as harboring IDH1/IDH2 mutations. Patients participating to the clinical trial will take the study drug as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. ;
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