M.D. Anderson Cancer Center
To find a recommended dose of HC-7366 to patients with AML. The safety and effects of this drug combination will also be studied.
Primary Objective: \- To evaluate safety of HC-7366 Secondary Objectives: * To estimate rate of CR/CRh/CRi by 4 cycles * To estimate overall response rate (ORR) * To estimate rate of MRD negative by 4 cycles * To estimate overall survival (OS) * To estimate relapse-free survival (RFS) Exploratory Objectives * To determine the plasma concentration and pharmacokinetic (PK) parameters of HC-7366 when dosed in combination with azole antifungals in AML patients. * To estimate duration of response (DOR) * To estimate median time to blood count recovery * To estimate median time to first respons…
Inclusion Criteria: 1. Patients need to have a confirmed diagnosis of AML, or MDS/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification. Dose escalation phase 2. Patients ≥18 years with R/R AML or R/R MDS/AML, other than acute promyelocytic leukemia (APL), with no available standard treatment options. 3. Relapsed or refractory disease defined by standard criteria as follows: a. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS b. R…
Given by PO
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