MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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).

Key facts

Study ID

NCT03008187

Run by

Menarini Group

People needed

73

Starts

2017-03-10

Expected to finish

2023-04-13

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Northside Hospital — Atlanta, Georgia, United States
• Cleveland Clinic, Taussig Cancer Institute — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Italy
• Istituto Clinico Humanitas — Milan, Italy
• ASST Monza - Ospedale San Gerardo — Monza, Italy
• Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi — Lodz, Poland
• Institute of Haematology and Blood Transfusion — Warsaw, Poland
• Institut Català d'Oncologia — Badalona, Spain
• Hospital 12 de Octubre — Madrid, Spain
• Hospital Universitari i Politecnic La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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