Clinical trial · Interventional
MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia
A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia
NCT03008187CI-TRIAL-00089073Diamond-01completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEN1703 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1 (25 mg)
- description
- Participants received MEN1703 (25 milligrams \[mg\]) orally once daily for 14 consecutive days in cycles of 21 days.
- interventionNames
- Drug: MEN1703
- type
- EXPERIMENTAL
- label
- Cohort 2 (50 mg)
- description
- Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.
- interventionNames
- Drug: MEN1703
- type
- EXPERIMENTAL
- label
- Cohort 3 (75 mg)
- description
- Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDMartinelli 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. PMID 41536779