Recruiting
Phase 1

STX-0712

Sponsor:

Solu Therapeutics, Inc

Code:

NCT06950034

Conditions

Chronic Myelomonocytic Leukemia

Chronic Myelomonocytic Leukemia (CMML)

Chronic Myelomonocytic Leukemia-1

Chronic Myelomonocytic Leukemia-2

Refractory Chronic Myelomonocytic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STX-0712

Study Details

Brief 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.

Conditions

Chronic Myelomonocytic Leukemia

Chronic Myelomonocytic Leukemia (CMML)

Chronic Myelomonocytic Leukemia-1

Chronic Myelomonocytic Leukemia-2

Refractory Chronic Myelomonocytic Leukemia

Study ID

NCT06950034

Start date

Mar 13, 2025

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

105 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation in CMML Patients

STX-0712 will be administered every 21 days.

experimental: Dose Escalation in AML Patients

STX-0712 will be administered every 21 days.

experimental: Dose Expansion in CMML

STX-0712 will be administered every 21 days.

experimental: Dose Expansion in AML

STX-0712 will be administered every 21 days.

Interventions

STX-0712

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

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) ]

Central Contacts and Locations

Central contacts

Head of Clinical Operations

01+ (781)-874-1100mtimothy@solutherapeutics.com

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Jack Taw

6507232781jtaw@stanford.edu

Principal Investigator:

Principal Investigator, MD

Moffitt

Recruiting

Tampa, Florida, United States, 12902

Contacts

Jhada Hunter

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

Jeff Edelman

Jeffrey.Edelman@moffitt.org

Principal Investigator:

Principal Investigator, MD

DFCI

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jessica Lee

617-632-4038jessica_lee@dfci.harvard.edu

Principal Investigator:

Principal Investigator, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amy Vagness

507-284-9523Vangness.amy@mayo.edu

Principal Investigator:

Principal Investigator, MBBS

OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

Emma Solanki

503-418-1034solankie@ohsu.edu

Tara Lundberg

lundbert@ohsu.edu

Principal Investigator:

Principal Investigator, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephany Hendrickson

UNKSLHendrickson@mdanderson.org

Research Nurse Manager

713-792-4478hnschneider@mdanderson.org

Principal Investigator:

Principal Investigator, MD

More Information

Sponsor

Solu Therapeutics, Inc

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Solu Therapeutics, Inc on 2026-02-09.