Actively Recruiting
A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
Led by Solu Therapeutics, Inc · Updated on 2026-02-09
105
Participants Needed
7
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of refractory or resistant CMML 1 or 2, with no response to at least 4 cycles of hypomethylating agents (HMAs) or hydroxyurea, or discontinued due to toxicity or progressive disease
- Relapsed or refractory monocytic or monocytic-predominant AML with at least 50% monocytes and/or monocytic precursors and certain monocytic markers
- Peripheral blood white blood cell count less than 30,000/microliter and less than 20% circulating blasts for monocytic AML
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Life expectancy greater than 2 months and stable enough to complete two cycles of STX-0712
- Adequate organ function
- Both females of child-bearing potential and males agree to use acceptable contraception during and for 90 days after treatment
- Able to understand and willing to sign informed consent
- Willing and able to comply with study procedures and follow-up
You will not qualify if you...
- Presence of other myelodysplastic/myeloproliferative neoplasm overlap syndromes for CMML or acute promyelocytic leukemia (APL) or isolated extramedullary disease for AML
- Eligible for immediate allogenic stem cell transplant
- Current active use of nicotine products including tobacco, nicotine patches, or vaping
- Prior bone marrow transplant within 6 months or immunosuppressive therapy within 3 months
- Active autoimmune conditions requiring immunosuppressive treatment or currently receiving such treatment
- Recent chemotherapy, biologic therapy, or wide-field radiation within 14 days before consent (hydroxyurea exceptions apply)
- Investigational treatment within 30 days before dosing
- Use of certain growth factors within 2 weeks before first dose
- Live or live attenuated vaccine within 30 days before first dose
- Significant cardiovascular disease or abnormal ECG findings
- Active malignancies other than AML or CMML requiring therapy, with exceptions for certain cancers
- Active, uncontrolled infections
- Known HIV infection
- Active or chronic hepatitis B or C infection
- Other severe or uncontrolled systemic diseases or conditions affecting safety or compliance
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
2
Moffitt
Tampa, Florida, United States, 12902
Actively Recruiting
3
DFCI
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
OHSU
Portland, Oregon, United States, 97239
Actively Recruiting
6
Vanderbilt University
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Head of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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