A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)

Must have received: hypomethylating agent — CMML

has not responded to at least 4 cycles of hypomethylating agents (HMAs)(for myeloproliferative CMML - HMAs or hydroxyurea) or discontinued prior to 4 cycles due to toxicity or has progressive disease

Cannot have received: bone marrow transplant

Exception: allowed if >6 months since transplant and >3 months since last immunosuppressive therapy

Prior bone marrow transplant (BMT) within 6 months of date of consent; or transplanted patients who received the last dose of immunosuppressive therapies within 3 months of date of consent

Cannot have received: chemotherapy, biologic therapy, or wide-field radiation

Exception: hydroxyurea may be continued up to 72 hours prior to first dose of STX-0712 and during first cycle for proliferative CMML or AML with high WBC

Received treatment with chemotherapy, biologic therapy, or wide-field radiation within 14 days of consent. Exceptions for hydroxyurea: For CMML and AML participants, hydroxyurea may be continued up to 72 hours prior to first dose of STX-0712. Hydroxyurea will also be permitted for first cycle of STX-0712 treatment for participants with proliferative CMML or AML with high white blood count (WBC ≥25,000/µL).

Cannot have received: investigational treatment

Received an investigational treatment within 30 days prior to dosing with STX-0712

Cannot have received: growth factors (Granulocyte Colony Stimulating Factor, Granulocyte Macrophage Colony Stimulating Factor, erythropoietin, romiplostim)

Received Granulocyte Colony Stimulating Factor [G-CSF], Granulocyte Macrophage Colony Stimulating Factor [GM-CSF], erythropoietin, romiplostim, or other growth factors within 2 weeks prior to first dose of STX- 0712

Cannot have received: live or live attenuated vaccine

Received a live or live attenuated vaccine within 30 days before the first dose of STX-0712