A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
Trial Parameters
Brief Summary
This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in patients with advanced CMML and AML for whom there are no further treatment options known to confer clinical benefit.
Eligibility Criteria
Inclusion Criteria: * Refractory/resistant CMML, defined as: Diagnosis of CMML 1 or 2; and 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 OR * Relapsed/refractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as ≥50% monocytes and/or monocytic precursors (promonocytes/monoblasts) and expressing at least two monocytic markers including CD4, CD11c, CD14, CD36, or CD64; and peripheral blood white blood cell (WBC) \<30,000/µL (microliters) and \<20% circulating blasts. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. * Life expectancy of \>2 months and stable enough to complete two cycles of STX-0712, in the opinion of the Investigator. * Adequate organ function. * Both females of child-bearing potential and males must agree to use acceptable contraceptive methods for the duration of time in