A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All eligible participants will be administered the study drug, STX-0712, as a single intravenous (IV) infusion every 21 days."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests STX-0712 in people with advanced CMML or AML, two types of blood cancer, who have no other treatments known to help. This is the first study of this drug in humans. It checks safety, how the drug acts in the body, and early signs that it may work.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have CMML type 1 or 2 that did not improve after at least 4 rounds of certain drugs, got worse, or required stopping those drugs early due to side effects. These drugs are hypomethylating agents (HMAs), or HMAs or hydroxyurea for the myeloproliferative form of CMML.
- Or have AML that came back or did not respond to treatment and mainly affects monocytes, a type of white blood cell. Tests must show at least 50% monocytes or their early forms and at least 2 required cell markers. Blood must have fewer than 30,000 white blood cells per microliter and fewer than 20% blasts (very young blood cells).
- Be able to care for yourself and be out of bed or a chair for at least half of waking hours.
- The study doctor expects you to live more than 2 months and be well enough to finish 2 rounds of STX-0712.
- Have organs that work well enough for the study.
- Men and women who could become pregnant must agree to use accepted birth control during the study and for 90 days after the last STX-0712 infusion.
- Be able to understand and willing to sign the study consent form.
- Be willing and able to follow study steps and attend follow-up exams.
Who can't join
- Have a related blood disorder other than CMML, acute promyelocytic leukemia (APL), or AML found only outside the bone marrow.
- Be eligible for an immediate stem cell transplant from a donor; have had a bone marrow transplant within 6 months before consent; or, after a transplant, have last taken drugs that lower immune activity within 3 months before consent.
- Currently use nicotine products, including tobacco, nicotine patches, or vaping products.
- Have an active autoimmune illness (when the immune system attacks the body) needing drugs that lower immune activity, or take these drugs for other reasons. Some steroids are allowed, including less than 10 mg daily of prednisone or an equal dose, and certain inhaled, skin, or local treatments.
- Have had chemotherapy, biological cancer treatment, or radiation to a large area within 14 days before consent; an experimental treatment within 30 days before the first dose; blood cell growth drugs within 2 weeks before the first dose; or a live vaccine within 30 days before the first dose. Hydroxyurea has special exceptions.
- Have serious heart or blood vessel disease, such as uncontrolled heart failure, chest pain, high blood pressure, or heart rhythm problems; a history of heart attack; or a stroke within 6 months before consent. A heart tracing showing a QTcF interval over 470 milliseconds also rules out joining.
- Have another active cancer or a cancer history needing treatment. Exceptions include non-melanoma skin cancer, certain cancers or abnormal cells that have not spread, and prostate cancer limited to the prostate that is not getting worse.
- Have an active, uncontrolled infection; known HIV; active or long-term hepatitis B or C; or another serious or unstable physical or mental health condition that could affect safety, consent, or following study steps.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (7)
CA
- Stanford University · Stanford, CA 94305Jack Taw · Study contact · 6507232781 · jtaw@stanford.eduPrincipal Investigator, MD · Principal investigatorMore trials in Stanford
FL
- Moffitt · Tampa, FL 12902Jhada Hunter · Study contact · (813)745-0286 · Jhada-Kai.Hunter@moffitt.orgJeff Edelman · Study contact · Jeffrey.Edelman@moffitt.orgPrincipal Investigator, MD · Principal investigatorMore trials in Tampa
MA
- DFCI · Boston, MA 02215Jessica Lee · Study contact · 617-632-4038 · jessica_lee@dfci.harvard.eduPrincipal Investigator, MD · Principal investigatorMore trials in Boston
MN
- Mayo Clinic · Rochester, MN 55905Amy Vagness · Study contact · 507-284-9523 · Vangness.amy@mayo.eduPrincipal Investigator, MBBS · Principal investigatorMore trials in Rochester
OR
- OHSU · Portland, OR 97239Emma Solanki · Study contact · 503-418-1034 · solankie@ohsu.eduTara Lundberg · Study contact · lundbert@ohsu.eduPrincipal Investigator, MD · Principal investigatorMore trials in Portland
TN
- Vanderbilt University · Nashville, TN 37232Jennifer Vanorden · Study contact · (615) 322-5000 · jennifer.vanorden@vumc.orgPrincipal Investigator, MBBS · Principal investigatorMore trials in Nashville
TX
- MD Anderson Cancer Center · Houston, TX 77030Stephany Hendrickson · Study contact · UNK · SLHendrickson@mdanderson.orgResearch Nurse Manager · Study contact · 713-792-4478 · hnschneider@mdanderson.orgPrincipal Investigator, MD · Principal investigatorMore trials in Houston