NCT06950034

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
14mo left

Started Mar 2025

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Mar 2025Jun 2027

Study Start

First participant enrolled

March 13, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

April 9, 2025

Last Update Submit

February 5, 2026

Conditions

CMMLChronic Myelomonocytic LeukemiaChronic Myelomonocytic Leukemia (CMML)Chronic Myelomonocytic Leukemia-1Chronic Myelomonocytic Leukemia-2Refractory Chronic Myelomonocytic LeukemiaAcute Myeloid LeukemiaAcute Myeloid Leukemia (AML)Acute Myeloid Leukemia Post Cytotoxic TherapyAcute Myeloid LeukemiasRefractory Acute Myeloid Leukemia (AML)Acute Monocytic Leukemia

Keywords

refractory/resistant CMMLCMMLAMLmonocytic AMLRelapsed/refractory AMLmonocytic-predominant AMLChronic Myelomonocytic LeukemiaAcute Myeloid LeukemiaRefractory Chronic Myelomonocytic LeukemiaRefractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (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

    Until the end of Dose Escalation (approximately 12 months)

Secondary Outcomes (8)

  • To evaluate the overall safety and tolerability of STX-0712

    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

    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

    Until the end of the study (approximately 24 months)

  • Pharmacokinetics of STX-0712: maximum concentration (Cmax)

    Until the end of the study (approximately 24 months)

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

    Until the end of the study (approximately 24 months)

  • +3 more secondary outcomes

Study Arms (4)

Dose Escalation in CMML Patients

EXPERIMENTAL

STX-0712 will be administered every 21 days.

Biological: STX-0712

Dose Escalation in AML Patients

EXPERIMENTAL

STX-0712 will be administered every 21 days.

Biological: STX-0712

Dose Expansion in CMML

EXPERIMENTAL

STX-0712 will be administered every 21 days.

Biological: STX-0712

Dose Expansion in AML

EXPERIMENTAL

STX-0712 will be administered every 21 days.

Biological: STX-0712

Interventions

STX-0712BIOLOGICAL

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

Dose Escalation in AML PatientsDose Escalation in CMML PatientsDose Expansion in AMLDose Expansion in CMML

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Moffitt

Tampa, Florida, 12902, United States

RECRUITING

DFCI

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

OHSU

Portland, Oregon, 97239, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelomonocytic, ChronicLeukemia, Myeloid, AcuteLeukemia, Monocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chief Medical Officer, MD, MSc, MBA

    Solu Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Head of Clinical Operations

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 29, 2025

Study Start

March 13, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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

Locations

US(7)