Clinical Trial Finder

Inclusion Criteria:

• - Patients with relapsed/refractory disease who have failed standard therapy or are unsuitable for standard treatment, with one the following confirmed diagnosis: AML as defined by the European LeukemiaNet (ELN) - Patients with confirmed diagnosis of AML as defined by the 2022 ELN recommendations.

• - Patients must have failed standard of care.

• - Adult (age ≥ 18 years) patients.

• - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

• - The interval from prior antitumor treatment to time of NMS-03592088 administration should be at least 2 weeks for any agents other than hydroxyurea.

• - All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTCAE version 5.0 Grade ≤1.

• - Adequate hepatic and renal function.

• - Patients must use highly effective contraception.

• - Signed and dated IEC or IRB-approved informed consent form.

Exclusion Criteria:

• - Current enrollment in another interventional clinical study.

• - Diagnosis of acute promyelocytic leukemia or Breakpoint cluster region-Abelson (BCR-ABL)-positive leukaemia.

• - Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and/or cone biopsied in situ carcinoma of the cervix uteri and/or superficial bladder cancer.

• - Patients with known leukemia involvement of central nervous system (CNS) - Hematopoietic stem cell transplantation (HSCT) within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade ≥2 related to the transplant.

• - Active acute or chronic graft versus host disease (GVHD) requiring immunosuppressive treatment.

• - Patients with QTcF interval ≥ 480 milliseconds or with risk factors for torsade de pointes.

• - Pregnancy.

• - Breast-feeding or planning to breast feed during the study or within 3 months after study treatment.

• - Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis.

• - Known active, life threatening or clinically significant uncontrolled systemic infection.

• - Known active gastrointestinal disease.

• - Known active gastrointestinal ulcer.

• - Other severe or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.

• - Known diagnosis of myasthenia gravis.

• - Signs or symptoms of myasthenia gravis or stroke during screening.

• - Patients with myasthenia gravis specific autoantibodies or any known history of myasthenia gravis (MG) autoantibodies at screening window.

• - Concomitant medications with the potential to cause de novo myasthenia gravis, worsening of myasthenia gravis or cause myasthenia gravis-like symptoms.

• - Uncontrolled hypertension, atrial fibrillation or flutter, ventricular arrhythmia or receiving treatment for cardiac rhythm disorder or diabetes that is not adequately controlled.

Arms

Interventions