Actively Recruiting
A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies
Led by Solu Therapeutics, Inc · Updated on 2026-02-09
105
Participants Needed
7
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, pharmacodynamics, and early effectiveness of STX-0712 in patients with advanced Chronic Myelomonocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML) who have no remaining treatment options known to provide clinical benefit. This is a first-in-human, open-label, phase 1 trial conducted in multiple centers, focusing on patients with refractory or resistant CMML and relapsed or refractory monocytic or monocytic-predominant AML. The study aims to understand dosing and initial effects of STX-0712. The study is divided into two parts: Dose Escalation and Dose Expansion. Dose Escalation will enroll CMML and AML patients in two cohorts to identify safe dosage levels using adaptive designs, followed by Dose Expansion cohorts to further evaluate these doses. STX-0712 is given as a single intravenous infusion every 21 days, and patients continue treatment until they meet criteria for discontinuation. Approximately 20 patients will be enrolled in each Dose Expansion cohort. Participants will undergo assessments to determine the maximum tolerated dose and minimum effective dose during Dose Escalation, lasting about 12 months. The overall safety, tolerability, anti-tumor activity, and pharmacokinetic and pharmacodynamic profiles of STX-0712 will be monitored for up to 24 months. Evaluations include laboratory tests, ECGs, and clinical examinations. Participants must comply with study visits and procedures during treatment and follow-up periods.
CONDITIONS
Brief 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...
- Adults aged 18 years and older
- Diagnosis of refractory or resistant Chronic Myelomonocytic Leukemia (CMML) 1 or 2 with prior treatment failure or toxicity
- Relapsed or refractory monocytic or monocytic-predominant Acute Myeloid Leukemia (AML) with specific monocytic markers and blood counts
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Life expectancy greater than 2 months and stable enough for two cycles of STX-0712 treatment
- Adequate organ function
- Agreement to use acceptable contraception during and for 90 days after treatment
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- Presence of myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes other than CMML
- Diagnosis of Acute Promyelocytic Leukemia (APL) or isolated extramedullary disease for AML
- Eligibility for immediate allogenic stem cell transplant
- Current active use of nicotine products
- Bone marrow transplant within 6 months or recent immunosuppressive therapy within 3 months
- Active autoimmune condition requiring immunosuppressive therapy beyond allowed steroids
- Recent chemotherapy, biologic therapy, or wide-field radiation within 14 days (with some exceptions)
- Use of investigational treatment within 30 days before dosing
- Recent use of certain growth factors within 2 weeks prior to first dose
- Live or live attenuated vaccine within 30 days before first dose
- Significant cardiovascular disease or abnormal ECG readings
- Active malignancies requiring treatment other than specified exceptions
- Active, uncontrolled infections
- Known HIV infection
- Active or chronic hepatitis B or C infection
- Other severe or uncontrolled systemic diseases or conditions that interfere with safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months during Dose Escalation, followed by additional treatment during Dose Expansion up to 24 months total study duration
Participants receive the study drug STX-0712 as a single intravenous infusion every 21 days until treatment discontinuation criteria are met.
Repeated infusions every 21 days
Duration - Up to 24 months from the start of the study
Participants are monitored for safety, tolerability, and anti-tumor activity after treatment ends, including pharmacokinetics and pharmacodynamics assessments.
Visits as scheduled for safety and efficacy assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here