A Phase Ia/Ib Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia Including Patients With TP53 Mutations
Nerviano Medical Sciences
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of refractory/relapsed (R/R) AML according to 2022 ELN recommendation: Phase Ia * single agent dose escalation of NMS-03597812: R/R AML patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy or b) prior unfit to IC: failed at least 2 cycles of hypomethylating agents (HMA)/venetoclax combination therapy, or at least 4 cycles of HMA monotherapy; c) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibito…
Interventions
- DrugNMS-03597812
Route of Administration: Oral
Locations (7)
- City of Hope - DuarteDuarte, California
- Rocky Mountain Cancer CentersAurora, Colorado
- Medical Oncology Hematology ConsultantsNewark, Delaware
- Blood and Marrow Transplant Group of GeorgiaAtlanta, Georgia
- Mayo Clinic Cancer Center (MCCC) - RochesterRochester, Minnesota
- Gabrail Cancer Research CenterCanton, Ohio