Actively Recruiting
A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
Led by Zhejiang ACEA Pharmaceutical Co. Ltd. · Updated on 2025-03-17
84
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study. * Dose escalation phase: rapid titration and conventional 3+3 test design were used to evaluate the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and PK characteristics of STI-8591. * Dose Expansion Phase: Evaluate the safety, preliminary efficacy and determine the recommended phase II dose (RP2D) of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose.
CONDITIONS
Official 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, secondary AML from myelodysplastic neoplasm, or AML with myelodysplastic-related changes per 2022 WHO criteria
- Failed standard therapy, intolerant to standard therapy, or unable to access standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Willing to undergo bone marrow aspiration/biopsy as required
- Laboratory tests within 7 days before first dose meeting specified limits for white blood cells, liver enzymes, bilirubin, and kidney function
- Residual toxicity from previous cancer treatments is grade 1 or less (except alopecia and hyperpigmentation)
- Willing and able to follow study schedule and protocol requirements
- Women of childbearing potential must have negative pregnancy test at screening
- Women of childbearing potential and male partners must use highly effective contraception from screening until 180 days after last treatment
- Provide FLT3 mutation status within 6 months before first dose or agree to testing during screening
You will not qualify if you...
- Known allergy to any component of the study drug
- Diagnosed with acute promyelocytic leukemia (APL)
- Positive for BCR-ABL leukemia
- Developed secondary AML after prior cancer treatments (except MDS or MDS/MPN)
- Central nervous system leukemia with symptoms
- Participated in another therapeutic clinical trial within 28 days before first dose (except survival follow-up)
- Received anti-tumor therapy within 28 days or 5 half-lives before first dose, or radiotherapy within 14 days before first dose (except palliative radiotherapy completed at least 7 days before)
- Grade 2 or higher graft-versus-host disease or systemic corticosteroid treatment for GvHD within 14 days before first dose
- Received CAR-T therapy within 3 months before first dose
- Used strong CYP450 2C8 or 3A4 enzyme inducers or inhibitors within 14 days before first dose unless necessary
- Major surgery within 28 days or minor surgery within 7 days before first dose (except biopsy or vascular access device insertion)
- Significant blood clotting disorders
- Uncorrectable low potassium or magnesium with recurrent episodes
- Active tuberculosis or interstitial lung disease requiring corticosteroids
- Uncontrolled active infection within 72 hours before first dose
- Unable to take oral medication or severe gastrointestinal disorders affecting drug absorption
- Recent serious blood clots within 3 months before first dose
- Active or uncontrolled hepatitis B, hepatitis C, or HIV infection
- Significant cardiovascular disease including recent heart failure, unstable angina, recent heart attack, uncontrolled arrhythmias, long QT syndrome, low heart function, uncontrolled hypertension, or recent stroke
- Pregnant or breastfeeding
- Serious mental illness or medical condition interfering with treatment or consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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