Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-8591 in Adults With Advanced Acute Myeloid Leukemia (AML)
Led by Zhejiang ACEA Pharmaceutical Co. Ltd. · Updated on 2025-03-17
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes the drug, and preliminary effectiveness of STI-8591 in adults with advanced acute myeloid leukemia (AML) or related myelodysplastic conditions who have failed or cannot tolerate standard treatments. This Phase I study focuses on finding the right dose and understanding the potential effects of STI-8591 in this serious blood cancer. The study includes a dose escalation phase to identify safe dosage levels and a dose expansion phase to further assess safety and early treatment responses. During the dose escalation phase, participants receive STI-8591 in increasing doses starting from 40 mg up to 280 mg per day using a rapid titration and traditional 3+3 design. The medication is taken twice daily in 28-day cycles, with specific fasting and dosing intervals. If preliminary signs of effectiveness appear, the dose expansion phase begins for selected dose groups, enrolling additional participants to better define the recommended dose for further studies. Dosing schedules and adjustments are based on ongoing safety and response data. Participants will undergo regular assessments including blood tests, bone marrow biopsies, and monitoring for side effects over the study period. Researchers will measure adverse events, drug levels in the body, effects on leukemia markers such as FLT3 plasma inhibitory activity, and various remission and survival outcomes up to about two years. The study includes careful safety monitoring and follow-up for up to three years to understand treatment effects and tolerability.
CONDITIONS
Brief Title
A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form voluntarily.
- Age 18 years or older.
- Expected survival longer than 12 weeks.
- Diagnosed with advanced primary AML, MDS secondary to AML, or AML-MR according to 2022 WHO criteria.
- Failed or intolerant to standard therapy or unable to access it.
- ECOG performance status of 0 to 2.
- Willing to undergo bone marrow aspiration/biopsy as required.
- Laboratory results within specified limits for white blood cell count, liver enzymes, bilirubin, and kidney function within 7 days before dosing.
- Residual toxicity from previous antitumor therapy is grade 1 or less (except alopecia and hyperpigmentation).
- Able and willing to follow study schedule and protocol.
- Women of childbearing potential with negative pregnancy test at screening.
- Use of highly effective contraception for women of childbearing potential and male partners from screening until 180 days after last treatment.
- Provide FLT3 mutation status within 6 months prior to first dose or willing to be tested during screening.
You will not qualify if you...
- Known allergy to any part of the study drug.
- Diagnosis of acute promyelocytic leukemia (APL).
- Presence of BCR-ABL positive leukemia.
- Secondary AML following prior antitumor therapy for other tumors (except MDS or MDS/MPN).
- Clinical symptoms of central nervous system leukemia.
- Participation in other therapeutic clinical trials within 28 days prior to first dose (except survival follow-up).
- Receipt of anti-tumor therapy or radiotherapy within specified timeframes before first dose.
- Grade 2 or higher graft-versus-host disease or related recent treatment.
- CAR-T therapy within 3 months before first dose.
- Use of strong CYP450 enzyme inducers or inhibitors within 14 days before first dose unless necessary.
- Recent major or minor surgery within specified timeframes.
- Significant coagulation disorders.
- Uncorrectable low potassium or magnesium levels with recurrent episodes.
- Active tuberculosis or certain lung diseases requiring corticosteroids.
- Uncontrolled active infections within 72 hours before first dose.
- Inability to take oral medication or severe gastrointestinal disorders affecting absorption.
- Recent serious thrombosis events within 3 months.
- Active or uncontrolled hepatitis B, hepatitis C, or HIV infection.
- Significant cardiovascular diseases including recent heart failure, unstable angina, recent myocardial infarction, uncontrolled arrhythmias, long QT syndrome, low heart function, uncontrolled hypertension, or recent stroke.
- Pregnant or breastfeeding women.
- Any serious mental illness or medical condition interfering with study participation or consent.
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 - Repeated 28-day cycles until disease progression or discontinuation
Participants receive STI-8591 orally twice daily in 28-day cycles with fasting requirements around dosing.
Visits at the end of Cycle 1 and the first day of Cycle 2 for pharmacokinetic assessments, plus regular visits during treatment
Duration - Up to 3 years
Participants are monitored for safety and efficacy outcomes including remission rates and survival for up to 3 years after treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jie Jin, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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