A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)

February 5, 2026 updated by: Solu Therapeutics, Inc

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, non-randomized phase 1 trial to assess the safety and preliminary efficacy of STX-0712 in refractory/resistant CMML and relapsed/refractory monocytic or monocytic-predominant AML. The study will be conducted in two parts: Dose Escalation (Part 1) and Dose Expansion (Part 2). Dose Escalation will accrue CMML and AML patients across 2 cohorts using the BOIN adaptive design, followed by Dose Expansion in both cohorts using Simon's 2-Stage Design. Cohort 1 will enroll approximately 3-6 CMML patients at each dose level. After at least two dose levels have been deemed safe in Cohort 1, the Sponsor may decide to open Cohort 2 to enroll AML patients. Approximately 20 patients will be enrolled in each Dose Expansion cohort. All eligible participants will be administered the study drug, STX-0712, as a single intravenous (IV) infusion every 21 days. Patients will remain on study therapy until treatment discontinuation criteria are met.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Principal Investigator, MD
    • Florida
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • DFCI
        • Principal Investigator:
          • Principal Investigator, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Principal Investigator, MBBS
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU
        • Principal Investigator:
          • Principal Investigator, MD
        • Contact:
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University
        • Principal Investigator:
          • Principal Investigator, MBBS
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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) or 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 bone marrow transplant (BMT) within 6 months of date of consent; or transplanted patients who received the last dose of immunosuppressive therapies within 3 months of date of consent.
  • Has active autoimmune condition requiring immunosuppressive treatment 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 treatment within 30 days prior to dosing with STX-0712.
  • Received 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.
  • Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled or unstable chest pain, history of heart attack(s), or stroke within 6 months prior to consent, uncontrolled high blood pressure, 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.
  • Active, uncontrolled bacterial, fungal, or viral infection.
  • Known human immunodeficiency virus (HIV).
  • Active or chronic hepatitis B or hepatitis C infection.
  • 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 participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation in CMML Patients
STX-0712 will be administered every 21 days.
Biological: STX-0712
STX-0712 is IV administered every 21 days until the patient discontinues treatment.
Experimental: Dose Escalation in AML Patients
STX-0712 will be administered every 21 days.
Biological: STX-0712
STX-0712 is IV administered every 21 days until the patient discontinues treatment.
Experimental: Dose Expansion in CMML
STX-0712 will be administered every 21 days.
Biological: STX-0712
STX-0712 is IV administered every 21 days until the patient discontinues treatment.
Experimental: Dose Expansion in AML
STX-0712 will be administered every 21 days.
Biological: STX-0712
STX-0712 is IV administered every 21 days until the patient discontinues treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the maximum tolerated dose (MTD) and/or minimum effective dose (MED)
Time Frame: Until the end of Dose Escalation (approximately 12 months)
Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period
Until the end of Dose Escalation (approximately 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the overall safety and tolerability of STX-0712
Time Frame: Until the end of the study (approximately 24 months)
Incidence of adverse events (AEs), characterized overall and by type, seriousness, relationship to study treatment, timing, and severity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Until the end of the study (approximately 24 months)
To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts
Time Frame: Until the end of the study (approximately 24 months)

Investigator-assessed overall response rate (ORR) as measured by standard response criteria:

For CMML: Proportion of participants achieving complete response (CR), complete cytogenetic remission, partial response (PR), marrow response, and clinical benefit according to the 2015 myelodysplastic/myeloproliferative neoplasms International Working Group (MDS/MPN IWG) criteria.

For AML: Proportion of participants achieving complete remission (CR), CR with partial hematologic recovery (CRh), complete remission with incomplete count recovery (CRi), morphological leukemia-free state (MLFS), and PR according to modified European Leukemia Network (ELN) 2022 criteria
Until the end of the study (approximately 24 months)
To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts
Time Frame: Until the end of the study (approximately 24 months)
Absolute decrease in peripheral blood monocytes by 50% from baseline in CMML and AML.
Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: maximum concentration (Cmax)
Time Frame: Until the end of the study (approximately 24 months)
maximum concentration (Cmax)
Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: time to reach maximum concentration (Tmax)
Time Frame: Until the end of the study (approximately 24 months)
time to reach maximum concentration (Tmax)
Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: area under the curve (AUC)
Time Frame: Until the end of the study (approximately 24 months)
Area under the curve (AUC)
Until the end of the study (approximately 24 months)
Pharmacokinetics of STX-0712: half-life (t½)
Time Frame: Until the end of the study (approximately 24 months)
Half-life (t½)
Until the end of the study (approximately 24 months)
To characterize the PD profile of STX-0712 after single and repeat-dose administration
Time Frame: Until the end of the study (approximately 24 months)
Decrease in tumor cells following STX-0712 dose STX-0712 single-dose and repeat-dose blood PD biomarkers of target activation
Until the end of the study (approximately 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solu Therapeutics, Inc

Investigators

  • Study Director: Chief Medical Officer, MD, MSc, MBA, Solu Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOLU-ONC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

First-in-Human study using a first-in-class compound.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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