Clinical Trial 23548

• Overview

  Study Title:

  A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients with Advanced Hematologic Malignancies

  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.

  Objective:

  Primary Objective: To determine the maximum tolerated dose (MTD) and/or minimum effective dose (MED). Secondary Objectives: To evaluate the overall safety and tolerability of STX-0712. To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts. To characterize the PK profile of STX-0712 (via measurement of STX-0196 and STX-0516) after single and repeat-dose administration. To characterize the PD profile of STX0712 after single and repeat-dose administration.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  STX-0712 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Has one of the following malignancies: Refractory/resistant CMML, defined as diagnosis of CMML 1 or 2 and no response to at least 4 cycles of hypomethylating agents (HMAs), Discontinued HMAs prior to 4 cycles due to toxicity or intolerability, progressive disease despite treatment. For myeloproliferative CMML: no prior response to hydroxyurea or to an HMA (≥4 cycles) is acceptable. OR Relapsed/refractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as >/=80% monocytes and/or their precursors (monoblasts and/or promonocytes), > 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.
  • Male or female, meeting one of the following criteria: Female, not of childbearing potential, Female of childbearing potential (FCBP): must have a documented negative serum or urine pregnancy test within 1 week prior to the first dose of STX-0712 treatment.
  • Females of child bearing potential and males must agree to use acceptable contraceptive methods for the entire duration of study participation AND for 90 days after last STX-0712 infusion. Acceptable methods of contraception are defined in the protocol and informed consent form.
  • 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

  Exclusion Criteria
  • For AML, has any of the following disease-specific conditions: Acute Promyelocytic Leukemia (APL), Isolated extramedullary disease.
  • Eligible for an immediate allogeneic stem cell transplant (alloSCT)
  • Current active use of nicotine-containing products including but not limited to tobacco, nicotine replacement therapy or vaping products.
  • Prior alloSCT unless all the following criteria are met: alloSCT was completed >6 months prior to consent, and Last dose of immunosuppressive therapy was >3 months prior to consent, and Last donor lymphocyte infusion was >3 months prior to consent, and No evidence of graft-versus-host disease (GVHD)
  • Has an active autoimmune condition requiring immunosuppressive therapy or is currently receiving immunosuppressive therapy for autoimmune disorders, allergies, or other clinical conditions. Exceptions (permitted): Systemic corticosteroids at doses > Received treatment with chemotherapy, biologic therapy, or wide-field radiation within 14 days of first dose of STX-0712. No washout period required for tyrosine kinase inhibitors (TKIs). Exceptions for hydroxyurea apply.
  • Received an investigational agent within 4 elimination half-lives prior to consent. If the half-life is unknown, within 30 days prior to consent.
  • Received hematopoietic cytokines: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), erythropoietin, romiplostim, (or other growth factors) within 2 weeks prior to first dose of STX-0712. Granulocyte colony stimulating factor (G-CSF), within 7 days prior to the 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 from prior chemotherapy that are CTCAE v5.0 Grade ≥1 and not adequately controlled with supportive care. Exceptions: alopecia, nausea, and fatigue
  • Clinically significant cardiovascular disease.
  • QT interval corrected by Fridericia's formula (QTcF) >470 msec for both males and females 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: nonmelanoma 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 central nervous system (CNS) involvement by disease. Exception: If CNS involvement is suspected based on clinical findings, the patient may be enrolled if CNS disease is ruled out by appropriate imaging and/or cerebrospinal fluid (CSF) examination.
  • 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) infection.
  • Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Known hypersensitivity to any of the components of STX-0712.
  • Evidence of any other severe or uncontrolled systemic diseases any other serious and/or unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could interfere with patient’s safety, obtaining informed consent, or compliance to the study procedures, in the opinion of the Investigator.

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