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New treatment option for Chronic Myelomonocytic Leukemia
Official title A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
ClinicalTrials.gov ID: NCT06950034
What this study is testing
What is STX-0712?
STX-0712 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic myelomonocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Relapsed/refractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as ≥50% monocytes and/or monocytic precursors...
- 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.
You likely can't join if
- Has any of the following disease-specific conditions: For CMML: Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes...
- 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...
- Has active autoimmune condition requiring immunosuppressive treatment or is receiving immunosuppressive therapy for the treatment of autoimmune...
- Received treatment with chemotherapy, biologic therapy, or wide-field radiation within 14 days of consent. Exceptions for hydroxyurea: For CMML and...
See the full eligibility 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...
- 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...
- 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...
- Able to understand and willing to sign a written informed consent form.
- Willing and able to comply with study procedures and follow-up examinations.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Portland, Oregon, United States; Nashville, Tennessee, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.