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Acute Myeloid LeukemiaPhase 1/2Diamond-01NCT03008187

MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia

A Phase 1/2 study testing MEN1703 in people with Acute Myeloid Leukemia, run by Menarini Group at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
MEN1703
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
15 sitesin 4 countries
Study dates
10 Mar 2017to 13 Apr 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States7 sites

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Cleveland Clinic, Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

Italy3 sites

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • Istituto Clinico Humanitas

    Milan

  • ASST Monza - Ospedale San Gerardo

    Monza

Other trials in Italy

Spain3 sites

  • Institut Català d'Oncologia

    Badalona

  • Hospital 12 de Octubre

    Madrid

  • Hospital Universitari i Politecnic La Fe

    Valencia

Other trials in Spain

Poland2 sites

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi

    Lodz

  • Institute of Haematology and Blood Transfusion

    Warsaw

Other trials in Poland

About this study

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

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).

Read the 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.

Being tested
MEN1703
Keywords
AML, Relapsed/Refractory Acute Myeloid Leukemia, IDH
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEN1703Drug

    Also called SEL24-B489, SEL24

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

Study groups in NCT03008187
Study groupRoleWhat they receive
Cohort 1 (25 mg)ExperimentalParticipants received MEN1703 (25 milligrams [mg]) orally once daily for 14 consecutive days in cycles of 21 days.
Receives: Drug: MEN1703
Cohort 2 (50 mg)ExperimentalParticipants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Receives: Drug: MEN1703
Cohort 3 (75 mg)ExperimentalParticipants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Receives: Drug: MEN1703
Cohort 4 (100 mg)ExperimentalParticipants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Receives: Drug: MEN1703
Cohort 5 (125 mg)ExperimentalParticipants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Receives: Drug: MEN1703
Cohort 6 (150 mg)ExperimentalParticipants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Receives: Drug: MEN1703

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and Part 2: Number of Participants Experiencing Treatment-emergent Adverse Events

    An adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the investigational medicinal product. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse events module.

    Measured: Up to 21 months

  2. Part 1: Number of Participants Experiencing Dose-limiting Toxicity (DLT)

    AEs were graded according to the National Cancer Institute common terminology criteria for adverse events, version 4.03. The following AEs were considered as DLT unless they were clearly and incontrovertibly attributable to the underlying disease or to an extraneous cause: Grade 5 toxicity; Grade 4 neutropenia lasting ≥42 days from the start of the therapy cycle in absence of evidence of active acute myeloid leukemia (AML) (<5% blasts); Grade 3 or 4 non-hematologic toxicity (with protocol-define exceptions). Only clinically significant abnormalities in laboratory findings, physical examination, vital signs, weight, or electrocardiogram were considered for DLT assessment.

    Measured: Day 1 through Day 21 (first treatment cycle)

Secondary outcomes (13)

  1. Part 1 and Part 2: Overall Response Rate (ORR)

    ORR was defined as the percentage of participants who had a complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission with partial hematologic recovery (CRh), or morphologic leukemia-free state (MLFS) response to therapy.

    Measured: Up to 32 months

  2. Part 1 and Part 2: Partial Remission (PR) Rate

    PR rate was defined as the percentage of participants who had a partial remission response to therapy.

    Measured: Up to 32 months

  3. Part 1 and Part 2: Duration of Response (DoR)

    DoR was defined as the time from the date of first CR, CRi, CRh, CR without minimal residual disease (CRMRD-), MLFS or PR until the date of documented relapse of any type, progressive disease or death due to disease progression for participants who achieve CR, CRi, CRh, CRMRD-, MLFS or PR. Results are reported in days.

    Measured: Up to 32 months

  4. Part 1 and Part 2: Relapse Free Survival (RFS)

    RFS was defined as the time from the date of first CR, CRi, CRh, or CRMRD- until the date of documented relapse or death from any cause. Results are reported in days.

    Measured: Up to 32 months

  5. Part 1 and Part 2: Overall Survival (OS)

    OS was defined as the number of days between the first study drug administration and death from any cause. Results are reported in days.

    Measured: Up to 32 months

  6. Part 1 and Part 2: Event Free Survival (EFS)

    EFS was defined as the time from the date of first study drug intake until the date of documented relapse, treatment failure, or death from any cause. Results are reported in days.

    Measured: Up to 32 months

  7. Part 1 and Part 2: Transfusion Conversion Rate

    Transfusion conversion rate was defined as the percentage of participants who were transfusion dependent at baseline but became transfusion independent post-baseline. Participants were classified as baseline transfusion independent if there were no red blood cells (RBC) or platelet transfusions at baseline; otherwise, the participant was considered as baseline transfusion dependent. Participants were classified post-baseline transfusion independent in the event of 56 consecutive days without any RBC or platelet transfusion post-baseline; otherwise, the participant was considered post-baseline transfusion dependent.

    Measured: Up to 21 months

  8. Part 1 and Part 2: Transfusion Maintenance Rate

    Transfusion maintenance rate was defined as the percentage of participants who were transfusion independent at baseline and still maintained to be transfusion independent post-baseline. Participants were classified as baseline transfusion independent if there were no RBC or platelet transfusions at baseline; otherwise, the participant was considered as baseline transfusion dependent. Participants were classified post-baseline transfusion independent in the event of 56 consecutive days without any RBC or platelet transfusion post-baseline; otherwise, the participant was considered post-baseline transfusion dependent.

    Measured: Up to 21 months

  9. Part 1 and Part 2: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Rate

    Allogeneic HSCT rate was defined as the percentage of participants undergoing allogeneic stem cell transplant during the study period of each participant.

    Measured: Up to 21 months

  10. Part 1 and Part 2: Percentage of Participants With ≥ 50% Bone Marrow Blast Reduction

    Bone marrow aspirates/biopsies were taken at designated timepoints for evaluation of leukemic blast proportion in the bone marrow. A reduction in bone marrow blast proportion indicates increased anti-leukemic activity of the study drug.

    Measured: Up to 20 months

  11. Part 1 and Part 2: Maximum Observed Concentration (Cmax) for MEN1703

    Nominal blood samples were taken at designated timepoints for evaluation of concentration levels of MEN1703 in plasma. Results are reported as nanograms/milliliter (ng/mL). Standard error not reported, arithmetic coefficient of variation (CV%) reported instead.

    Measured: Day 1 and Day 14 of Cycle 1 (pre-dose, up to 120 hours post dose) (21 days/cycle)

  12. Part 1 and Part 2: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for MEN1703

    Nominal blood samples were taken at designated timepoints for evaluation of concentration levels of MEN1703 in plasma. AUClast was calculated by the linear trapezoidal rule. Results are reported in hour times nanograms/milliliter (h*ng/mL). Standard error not reported, arithmetic CV% reported instead.

    Measured: Day 1 of Cycle 1 (pre-dose, up to 24 hours post dose) (21 days/cycle)

  13. Part 1 and Part 2: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) for MEN1703

    Nominal blood samples were taken at designated timepoints for evaluation of concentration levels of MEN1703 in plasma. AUC0-24 was calculated by the linear trapezoidal rule. Results are reported in h*ng/mL. Standard error not reported, arithmetic CV% reported instead.

    Measured: Day 14 of Cycle 1 (pre-dose, up to 120 hours post dose) (21 days/cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start10 Mar 2017
  3. Primary completion13 Apr 2023
  4. Study completion13 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008187
Sponsor's protocol ID
CLI24-001
Acronym
Diamond-01
Status last verified
Mar 2025
First submitted
10 Dec 2016
Last updated
29 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Martinelli G, Solomon SR, Mukherjee S, Santoro A, Strickland SA, Vives S, Ravandi F, Walter RB, Cook RJ, Lech-Maranda E, Calbacho M, Wierzbowska A, Marconi G, Acuna-Cruz E, Cano-Ferri I, Bertolini F, Rzymski T, Paoli A, Merlo GM, Auriol FK, Zicari S, Galleu A, Gupta I, Montesinos P. Dual FLT3/PIM inhibitor dapolsertib in acute myeloid leukemia: results from the phase 1/2 DIAMOND-01 trial. Blood Neoplasia. 2025 Oct 24;3(1):100178. doi: 10.1016/j.bneo.2025.100178. eCollection 2026 Feb.

    PubMed 41536779

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MEN1703 in people with Acute Myeloid Leukemia, run by Menarini Group at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Italy, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and Part 2: Number of Participants Experiencing Treatment-emergent Adverse Events (time frame: Up to 21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03008187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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