SEL24 / MEN1703 in Patients With Acute Myeloid Leukemia
- patients with diagnosis of Acute Myeloid Leukemia
- Patient has no standard therapeutic options available and has either Relapsed AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy or Primary refractory AML unsuitable for intensive chemotherapy and not eligible for any approved targeted therapy
- anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy or investigational drugs) received within 14 days or 5 half-lives for targeted therapies (whichever is shorter) before first dose of study drug (to be supplemented)
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
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.
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.
Trial Phase Phase I/II
Trial Type Treatment
- Primary ID CLI24-001
- Secondary IDs NCI-2017-00611
- Clinicaltrials.gov ID NCT03008187