A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)

Required: FLT3 mutation

Subjects are required to provide FLT3 mutation status testing within 6 months prior to the first dose, and if not, are willing to undergo screening period testing as required by the protocol.

Excluded: BCR ABL fusion

Subjects have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).

Must have received: standard therapy

have failed standard therapy or are intolerant of standard therapy

Cannot have received: anti-tumor therapy

Exception: except MDS, MDS/MPN

secondary AML after previous antitumor therapy for other tumors (except MDS, MDS/MPN)

Cannot have received: anti-tumor therapy

Received anti-tumor therapy (including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, etc.) within 28 days or 5 half-lives (whichever is shorter) prior to the first dose.

Cannot have received: radiation therapy

Exception: palliative radiotherapy for symptom control is allowed to be completed at least 7 days prior to the first dose

Received radiotherapy within 14 days prior to the first dose.

Cannot have received: herbal therapy with approved indications for antitumor use

Have received herbal therapy with approved indications for antitumor use within 7 days prior to the first dose.

Cannot have received: CAR-T cell therapy

Received chimeric antigen receptor T-cell immunotherapy (CAR-T) within 3 months prior to the first dose.