Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia

The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.

Trial Details

NCT ID
NCT06549790
Phase
PHASE1
Sponsor
Nerviano Medical Sciences
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • NMS-03597812
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Newark, Delaware, United States|39.68372,-75.74966
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Rochester, Minnesota, United States|44.02163,-92.4699

Key Eligibility Criteria

  • Confirmed diagnosis of refractory/relapsed (R/R) AML according to 2022 ELN recommendation:
  • single agent dose escalation of NMS-03597812: R/R AML patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy…
  • Cohort A: single agent in R/R AML TP53mt patients who have exhausted standard therapy: a) prior unfit to intensive chemotherapy (IC): failed at lea…
  • Cohort B: single agent in R/R AML TP53wt patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed…

For full eligibility, visit ClinicalTrials.gov.

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