Phase 2
N=25
MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT03008187 ↗Enrolled (actual)
25
Serious AEs
65.8%
Results posted
Apr 2025
Primary outcome: Primary: Part 1 and Part 2: Number of Participants Experiencing Treatment-emergent Adverse Events — 2; 3; 3; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEN1703 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Menarini Group
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1 and Part 2: Number of Participants Experiencing Treatment-emergent Adverse Events |
2; 3; 3; 6; 54; 4 | — |
| PRIMARY Part 1: Number of Participants Experiencing Dose-limiting Toxicity (DLT) |
1; 0; 0; 0; 1; 3 | — |
| SECONDARY Part 1 and Part 2: Overall Response Rate (ORR) |
0; 50.0; 0; 13.5; 0 | — |
| SECONDARY Part 1 and Part 2: Partial Remission (PR) Rate |
0; 0; 0; 0; 0 | — |
| SECONDARY Part 1 and Part 2: Duration of Response (DoR) |
NA; 79.0; NA; 63.0; NA | — |
| SECONDARY Part 1 and Part 2: Relapse Free Survival (RFS) |
NA; 81.0; NA; 64.0; NA | — |
| SECONDARY Part 1 and Part 2: Overall Survival (OS) |
43.0; 138.5; NA; 144.0; 42.5 | — |
| SECONDARY Part 1 and Part 2: Event Free Survival (EFS) |
15.0; 14.0; 14.0; 43.0; 15.0 | — |
| SECONDARY Part 1 and Part 2: Transfusion Conversion Rate |
25 | — |
| SECONDARY Part 1 and Part 2: Transfusion Maintenance Rate |
100 | — |
| SECONDARY Part 1 and Part 2: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Rate |
2.7 | — |
| SECONDARY Part 1 and Part 2: Percentage of Participants With ≥ 50% Bone Marrow Blast Reduction |
0; 50.0; 0; 33.3; 0 | — |
| SECONDARY Part 1 and Part 2: Maximum Observed Concentration (Cmax) for MEN1703 |
8.77; 33.58; 60.55; 73.25; 152.94; 249.00 | — |
| SECONDARY Part 1 and Part 2: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) for MEN1703 |
152.17; 490.37; 729.48; 1016.62; 1936.61; 2608.31 | — |
| SECONDARY Part 1 and Part 2: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) for MEN1703 |
1330.03; 2885.33; 5574.10; 9224.62; 15769.60 | — |
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).
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)
Data sourced from ClinicalTrials.gov (NCT03008187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.