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Chronic Myelomonocytic LeukemiaPhase 1NCT06950034

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

A Phase 1 study testing STX-0712 in people with Chronic Myelomonocytic Leukemia and Chronic Myelomonocytic Leukemia (CMML), run by Solu Therapeutics, Inc at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
STX-0712
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
7 sitesUnited States
Study dates
13 Mar 2025to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 16Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Head of Clinical Operations contact

01+ (781)-874-1100

mtimothy@solutherapeutics.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • DFCI

    Boston, Massachusetts, 02215

    Jessica Lee, 617-632-4038, jessica_lee@dfci.harvard.edu

    Principal Investigator, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Stephany Hendrickson, UNK, SLHendrickson@mdanderson.org

    Research Nurse Manager, 713-792-4478, hnschneider@mdanderson.org

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Jennifer Vanorden, (615) 322-5000, jennifer.vanorden@vumc.org

    Principal Investigator, MBBS

    Not yet recruiting

  • OHSU

    Portland, Oregon, 97239

    Emma Solanki, 503-418-1034, solankie@ohsu.edu

    Tara Lundberg, lundbert@ohsu.edu

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Amy Vagness, 507-284-9523, Vangness.amy@mayo.edu

    Principal Investigator, MBBS

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Jack Taw, 6507232781, jtaw@stanford.edu

    Principal Investigator, MD

    Recruiting

  • Moffitt

    Tampa, Florida, 12902

    Jhada Hunter, (813)745-0286, Jhada-Kai.Hunter@moffitt.org

    Jeff Edelman, Jeffrey.Edelman@moffitt.org

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
STX-0712
Keywords
refractory/resistant CMML, CMML, AML, monocytic AML, Relapsed/refractory AML, monocytic-predominant AML, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia, Refractory Chronic Myelomonocytic Leukemia, Refractory Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, Leukemia, Monocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STX-0712Biological

    STX-0712 is IV administered every 21 days until the patient discontinues treatment.

Study groups in NCT06950034
Study groupRoleWhat they receive
Dose Escalation in CMML PatientsExperimentalSTX-0712 will be administered every 21 days.
Receives: Biological: STX-0712
Dose Escalation in AML PatientsExperimentalSTX-0712 will be administered every 21 days.
Receives: Biological: STX-0712
Dose Expansion in CMMLExperimentalSTX-0712 will be administered every 21 days.
Receives: Biological: STX-0712
Dose Expansion in AMLExperimentalSTX-0712 will be administered every 21 days.
Receives: Biological: STX-0712

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose (MTD) and/or minimum effective dose (MED)

    Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period

    Measured: Until the end of Dose Escalation (approximately 12 months)

Secondary outcomes (8)

  1. To evaluate the overall safety and tolerability of STX-0712

    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

    Measured: Until the end of the study (approximately 24 months)

  2. To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts

    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

    Measured: Until the end of the study (approximately 24 months)

  3. To evaluate the initial anti-tumor activity of STX-0712 in the CMML and AML cohorts

    Absolute decrease in peripheral blood monocytes by 50% from baseline in CMML and AML.

    Measured: Until the end of the study (approximately 24 months)

  4. Pharmacokinetics of STX-0712: maximum concentration (Cmax)

    maximum concentration (Cmax)

    Measured: Until the end of the study (approximately 24 months)

  5. Pharmacokinetics of STX-0712: time to reach maximum concentration (Tmax)

    time to reach maximum concentration (Tmax)

    Measured: Until the end of the study (approximately 24 months)

  6. Pharmacokinetics of STX-0712: area under the curve (AUC)

    Area under the curve (AUC)

    Measured: Until the end of the study (approximately 24 months)

  7. Pharmacokinetics of STX-0712: half-life (t½)

    Half-life (t½)

    Measured: Until the end of the study (approximately 24 months)

  8. To characterize the PD profile of STX-0712 after single and repeat-dose administration

    Decrease in tumor cells following STX-0712 dose STX-0712 single-dose and repeat-dose blood PD biomarkers of target activation

    Measured: Until the end of the study (approximately 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start13 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a Dose Escalation and Dose expansion study testing STX-0712 in 2 indications: CMML (Cohort 1) and Monocytic and/or monocytic predominant AML (Cohort 2).
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06950034
Sponsor's protocol ID
SOLU-ONC-001
Status last verified
Feb 2026
First submitted
9 Apr 2025
Last updated
9 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: First-in-Human study using a first-in-class compound.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STX-0712 in people with Chronic Myelomonocytic Leukemia and Chronic Myelomonocytic Leukemia (CMML), run by Solu Therapeutics, Inc at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Head of Clinical Operations (01+ (781)-874-1100, mtimothy@solutherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD) and/or minimum effective dose (MED) (time frame: Until the end of Dose Escalation (approximately 12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06950034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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