Has any of the following disease-specific conditions:
Eligible for an immediate allogenic stem cell transplant (alloSCT)
Current active use of nicotine products including tobacco, nicotine patches or vaping products
Prior alloSCT unless the alloSCT was completed >6 months prior to consent, last dose of immunosuppressive agent was >3 months prior to consent, last donor lymphocyte infusion was >3 months prior to consent, and no evidence of graft versus host disease
Has active autoimmune condition requiring immunosuppressive agents or is receiving immunosuppressive therapy for the treatment of autoimmune disorders, allergies, or other clinical symptoms. Systemic steroids <10 mg (milligrams) daily of prednisone equivalent are allowed; and intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids are allowed.
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).
Received an investigational agent within 4 elimination half-lives prior to consent (or 30 days in case half-life unknown)
Received hematopoietic cytokines (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
Received a live or live attenuated vaccine within 30 days before the first dose of STX-0712
Persistent clinically significant toxicities CTCAE grade ≥1 from previous chemotherapy not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue)
Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to consent, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication)
QT interval corrected by Fridericia's formula (QTcF) >470 msec for both men and women on Screening electrocardiogram(s) (ECG). Patients with a bundle branch block must have QT interval corrected for bundle branch block.
Other than AML or CMML, active malignancy and/or cancer history that requires active therapy. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.
Known or suspected disease involvement of the central nervous system (CNS). If suspected due to clinical findings, patient may be enrolled if CNS disease is ruled out with relevant imaging and/or examination of cerebrospinal fluid.
Active, uncontrolled bacterial, fungal, or viral infection. Patients who are on systemic therapy are allowed if hemodynamically stable and with negative blood cultures and after review by Medical Monitor.
Known human immunodeficiency virus (HIV)
Active or chronic hepatitis B or hepatitis C infection
Known hypersensitivity to any of the components of STX-0712
Evidence of any other severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes), any other serious and/or unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could interfere with participant’s safety, obtaining informed consent, or compliance to the study procedures, in the opinion of the Investigator