SNDX-5613 Clinical Trials

AUGMENT-101

CLINICAL TRIAL NOW RECRUITING: Adult and pediatric relapsed/refractory patients with MLLr or mNPM1 acute leukemias

AUGMENT-101 (NCT04065399) is a Phase 1/2 trial investigating orally administered SNDX-5613 in patients with MLLr or mNPM1 acute leukemias1,2

Intervention: SNDX-5613 capsules orally. Enroll: If you are interested in learning more about enrolling your patients in Augment-101, contact us directly at clinicaltrials@syndax.com
Intervention: SNDX-5613 capsules orally. Enroll: If you are interested in learning more about enrolling your patients in Augment-101, contact us directly at clinicaltrials@syndax.com
SNDX-5613 is an investigational, novel, orally available Menin-MLL1 inhibitor.2 The interaction of Menin and MLL1 has been demonstrated to play an essential role in the leukemic transformation for acute leukemia patients with MLLr or NPM1 mutation.3,4

Prevalence5

  • MLL rearrangements are found in 5% to 10% of adult AML and B-ALL cases and >70% of infant leukemias
  • NPM1 mutations are found in about 25% to 30% of all adult AML
AUGMENT-101/NCT04065399: A Phase 1/2, Open-Label, dose-escalation and dose-expansion cohort study of SNDX-5613 in patients with relapsed/ refractory acute leukemias harboring a mixed lineage leukemia (MLL)/KMT2A gene rearrangement or Nucleophosmin 1 (NPM1) mutation.1
This trial is actively recruiting
For full trial information, see this trial on ClinicalTrials.gov
If you are interested in learning more about enrolling your patients in AUGMENT-101,
contact us directly at clinicaltrials@syndax.com.
References

  1. A study of SNDX-5613 in R/R leukemias including those with an MLLr/KMT2A gene rearrangement or NPM1 mutation (AUGMENT-101). ClinicalTrials.gov identifier: NCT04065399. https://clinicaltrials.gov/ct2/show/NCT04065399. Updated September 16, 2019.
    Accessed November 12, 2019.
  2. Data on file. Syndax Pharmaceuticals, Inc.
  3. Kuhn MW, Armstrong SA. Designed to kill: novel menin-MLL inhibitors target MLL-rearranged leukemia. Cancer Cell. 2015;27(4):431-433.
  4. Kuhn MW, Song E, Feng Z, et al. Targeting chromatin regulators inhibits leukemogenic gene expression in NPM1 mutant leukemia. Cancer Discov. 2016;6(10):1166–1181.
  5. Ley TJ, Miller C, Ding L, et al. Genomic and epigenomic landscapes of adult de novo acute myeloid leukemia. N Engl J Med. 2013;368(22):2059–2074.