Vanderbilt Clinical Trials

MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia

Purpose

The purpose of the clinical trial is to identify the maximum tolerated dose of MEN1703 and to further investigate its safety profile in participants with acute myeloid leukemia (AML).

Condition

Acute Myeloid Leukemia

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Participants with diagnosis of AML, all comers or bearing IDH1 or IDH2 mutation (completed) - Participant has no standard therapeutic options available and has either relapsed AML unsuitable for intensive chemotherapy, with no standard therapeutic options and/or not eligible for any approved targeted therapy or primary refractory AML unsuitable for intensive chemotherapy, with no standard therapeutic options and/or 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)

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1 (25 mg)	Participants received MEN1703 (25 milligrams [mg]) orally once daily for 14 consecutive days in cycles of 21 days.	Drug: MEN1703 MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Other names: SEL24-B489 SEL24
Experimental Cohort 2 (50 mg)	Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Drug: MEN1703 MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Other names: SEL24-B489 SEL24
Experimental Cohort 3 (75 mg)	Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Drug: MEN1703 MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Other names: SEL24-B489 SEL24
Experimental Cohort 4 (100 mg)	Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Drug: MEN1703 MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Other names: SEL24-B489 SEL24
Experimental Cohort 5 (125 mg)	Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Drug: MEN1703 MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Other names: SEL24-B489 SEL24
Experimental Cohort 6 (150 mg)	Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.	Drug: MEN1703 MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Other names: SEL24-B489 SEL24

More Details

Status: Completed
Sponsor: Menarini Group

Study Contact

Detailed Description

Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated dose of MEN1703 in participants with acute myeloid leukemia. The clinical trial will investigate the safety profile and anti-leukemic activity of MEN1703 in participants with AML and that have no standard therapeutic options available. The clinical trial encompasses 2 parts: - Part 1: Ascending dose levels - the main purpose of this part of the clinical trial is to determine the highest dose of 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 MEN1703 given at the highest tolerated dose in participant with relapsed/refractory acute myeloid leukemia, either all comers as well as harboring isocitrate dehydrogenase (IDH1/IDH2) mutations. Participants 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.