A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease
SNDX-5613, a menin inhibitor, is being evaluated in combination with standard chemotherapy (daunorubicin and cytarabine) for newly diagnosed acute myeloid leukemia (AML) patients with specific genetic alterations (NPM1 mutations, MLL/KMT2A rearrangements, or NUP98 alterations). The trial's focus on high-risk AML patients positions it strategically within a niche market, potentially addressing unmet needs in a competitive landscape dominated by existing therapies. The combination approach may enhance efficacy and improve patient outcomes, which could lead to a favorable market entry if successful. The trial is sponsored by the National Cancer Institute, indicating a robust backing that may enhance credibility and attract further investment or partnerships.
Indication: Acute Myeloid Leukemia
Modality: small molecule
Target: Menin-KMT2A protein-protein interactions
Sponsor: National Cancer Institute (NCI)
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 17, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Menin-KMT2A protein-protein interactions
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Condition raw: Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Secondary Acute Myeloid Leukemia
Condition normalized: Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Secondary Acute Myeloid Leukemia
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Menin-KMT2A protein-protein interactions
Target normalized: Menin-KMT2A protein-protein interactions