A Study of STX-0712 in Patients with Advanced Hematologic Malignancies

Overview

About this study

The purpose of this study is to evaluate the safety and preliminary efficacy of STX-0712 in patients with advanced hematologic malignancies CMML and AML for whom there are no further treatment options known to confer clinical benefit.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Has one of the following hematologic malignancies:
    • 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 a monocytic immunophenotype defined by expression of 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
  • Age ≥18 years
  • 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:
    • Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 x upper limit of normal (ULN). In patients with CMML or AML with potential liver involvement, AST/ALT ≤5 x ULN
    • Serum bilirubin – total ≤1.5 x ULN (unless due to Gilbert’s syndrome, hemolysis or CMML or AML with potential liver involvement, in which case total ≤3.0 x ULN)
    • Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 (milliliters per minute per 1.73 square meters of body surface area) as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021)
  • Male or female meeting one of the following criteria:
    • Female not of childbearing potential, specifically:
      • Pre-menopausal with a documented tubal ligation or hysterectomy, or
      • Postmenopausal, defined as 12 months or longer of spontaneous amenorrhea. If the length of spontaneous amenorrhea is unknown or equivocal, simultaneous follicle stimulating hormone (FSH) >40 MlU/mL (milli-international units per milliliter) and estradiol <40 pg/mL (picograms per milliliter) (<140 pmol/L [picomoles per liter]) are required.
    • Female of childbearing potential (FOCBP) who has a negative serum or urine pregnancy test within 1 week prior to STX-0712 treatment
  • 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

Exclusion Criteria:

  • Has any of the following disease-specific conditions:
    • For CMML:
      • Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes other than CMML
    • For AML:
      • Acute Promyelocytic Leukemia (APL)
      • Isolated extramedullary disease
  • 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 02/12/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Abhishek Mangaonkar, M.B.B.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available