MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia

NCT ID: NCT03008187

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-10
• Study Completion Date: 2023-04-13

Brief Summary

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).

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (25 mg)

Participants received MEN1703 (25 milligrams \[mg\]) orally once daily for 14 consecutive days in cycles of 21 days.

Group Type: EXPERIMENTAL

MEN1703

Intervention Type: DRUG

MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Cohort 2 (50 mg)

Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Group Type: EXPERIMENTAL

MEN1703

Intervention Type: DRUG

MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Cohort 3 (75 mg)

Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Group Type: EXPERIMENTAL

MEN1703

Intervention Type: DRUG

MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Cohort 4 (100 mg)

Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Group Type: EXPERIMENTAL

MEN1703

Intervention Type: DRUG

MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Cohort 5 (125 mg)

Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Group Type: EXPERIMENTAL

MEN1703

Intervention Type: DRUG

MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Cohort 6 (150 mg)

Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Group Type: EXPERIMENTAL

MEN1703

Intervention Type: DRUG

MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Interventions

MEN1703

MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Intervention Type: DRUG

Other Intervention Names

SEL24-B489; SEL24

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Theradex

INDUSTRY

Sponsor Role: collaborator

Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Italy; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLI24-001

Identifier Type: -

Identifier Source: org_study_id