OncoMatch/Clinical Trials/NCT06549790
Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia
Is NCT06549790 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NMS-03597812 for relapsed/refractory acute myeloid leukemia.
Treatment: NMS-03597812 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: TP53 mutation
Required: TP53 wild-type
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive chemotherapy — front-line
prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy
Must have received: hypomethylating agent/venetoclax combination therapy
failed at least 2 cycles of HMA/venetoclax combination therapy
Must have received: hypomethylating agent
failed at least 4 cycles of HMA monotherapy
Must have received: FLT3 inhibitor
patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors
Must have received: IDH1 inhibitor
patients must have failed all other approved therapies for which they are eligible, including ... IDH1/2 inhibitors
Must have received: IDH2 inhibitor
patients must have failed all other approved therapies for which they are eligible, including ... IDH1/2 inhibitors
Must have received: CD33 directed therapy
patients must have failed all other approved therapies for which they are eligible, including ... CD33 directed therapy
Cannot have received: hematopoietic stem cell transplantation
Exception: within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade ≥2 related to the transplant
Hematopoietic stem cell transplantation (HSCT) within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade ≥2 related to the transplant
Cannot have received: radiotherapy
Exception: if the radiation portal covered ≤5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy
Radiotherapy within 4 weeks before study treatment start. However, if the radiation portal covered ≤5 % of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy.
Cannot have received: major surgery
Major surgery within 4 weeks before study treatment start.
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope - Duarte · Duarte, California
- Rocky Mountain Cancer Centers · Aurora, Colorado
- Medical Oncology Hematology Consultants · Newark, Delaware
- Blood and Marrow Transplant Group of Georgia · Atlanta, Georgia
- Mayo Clinic Cancer Center (MCCC) - Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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