Phase I Study of HC-7366 for Acute Myeloid Leukemia

Allowed: TP53 mutation

Participants relapsing with persistent or new TP53 mutation will be eligible irrespective of CR1 duration.

Allowed: FLT3 actionable mutation

Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.

Allowed: IDH1 actionable mutation

Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.

Allowed: IDH2 actionable mutation

Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.

Must have received: intensive induction chemotherapy (purine analogue containing intensive induction chemotherapy regimen (e.g., FLAG-Ida, CLIA or CLAG-M or similar regimens with or without venetoclax), intensive induction chemotherapy with venetoclax (e.g., 7 + 3 or CPX-251 with venetoclax or similar regimens), intensive induction chemotherapy such as 7 + 3 or 5 + 2 or similar regimens without venetoclax, venetoclax with HMA/LDAC +/- other agents, HMA alone) — relapsed or refractory

Appropriate prior therapy in order for patient to be deemed relapsed or refractory include any of the following: i. At least 1 cycle of purine analogue containing intensive induction chemotherapy regimen, e.g., FLAG-Ida, CLIA or CLAG-M or similar regimens with or without venetoclax. ii. At least 1 cycle of intensive induction chemotherapy with venetoclax, e.g., 7 + 3 or CPX-251 with venetoclax or similar regimens iii. At least 2 cycles of intensive induction chemotherapy such as 7 + 3 or 5 + 2 or similar regimens without venetoclax iv. 2 cycles of venetoclax with HMA/LDAC +/- other agents v. 4 cycles of HMA alone

Cannot have received: cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies

Exception: hydroxyurea or cytarabine for control of WBC count during washout period is permitted

Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.