NCT06950034 A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
| NCT ID | NCT06950034 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Solu Therapeutics, Inc |
| Condition | Chronic Myelomonocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 105 participants in total. It began in 2025-03-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Chief Medical Officer, MD, MSc, MBA
STUDY DIRECTOR
Solu Therapeutics
Frequently Asked Questions
Who can join the NCT06950034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Myelomonocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06950034 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06950034 currently recruiting?
Yes, NCT06950034 is actively recruiting participants. Contact the research team at mtimothy@solutherapeutics.com for enrollment information.
Where is the NCT06950034 trial being conducted?
This trial is being conducted at Stanford, United States, Tampa, United States, Boston, United States, Rochester, United States and 3 additional locations.
Who is sponsoring the NCT06950034 clinical trial?
NCT06950034 is sponsored by Solu Therapeutics, Inc. The principal investigator is Chief Medical Officer, MD, MSc, MBA at Solu Therapeutics. The trial plans to enroll 105 participants.
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