SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: SEL24/MEN1703


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with diagnosis of Acute Myeloid Leukemia, all comers (completed) and bearing IDH1 or IDH2 mutation (open for recruitment) 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEL24/MEN1703<br>SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Part 1: ascending dose levels (cohort) will be tested in at least 3 patients. Any cohort in which 1 patient experiences a dose-limiting toxicity will be expanded up to 6 patients. Part 2: testing at the dose of SEL24/MEN1703 which have demonstrated to be adequately tolerated in Part 1. | Drug: SEL24/MEN1703<br>* SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.<br>* Other names: MEN1703;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity (DLT) evaluation | Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate | DLTs in patients during their first 21-day treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of single agent SEL24/MEN1703 | Number and frequency of AEs | From Cycle 1 Day 1 to Final Study Visit (up to 30 days after last administered dose). Each Cycle lasts 21 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Relapsed/Refractory Acute Myeloid Leukemia, IDH