A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies
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.
• 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 the study and to continue to use acceptable contraceptive methods for 90 days after last STX-0712 infusion.
• Able to understand and willing to sign a written informed consent form.
• Willing and able to comply with study procedures and follow-up examinations.