BridgeMD
New treatment option for AML, Adult
Official title A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT05947344
What this study is testing
What is STI-8591?
STI-8591 is an investigational medicine, being studied as a potential treatment for aml, adult.
Also referred to as STI-8591 alone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be enrolled in this study, people must meet all of the following .
- Voluntary signing of ICF.
- Age ≥ 18 years old.
- Expected survival \>12 weeks.
- Dose escalation component: Advanced primary AML or myelodysplastic neoplasm (MDS) secondary to AML or MDS/myeloproliferative neoplasm...
You likely can't join if
- To be enrolled in this study, people must not meet any of the following exclusion criteria.
- Known hypersensitivity to any component of the study drug formulation.
- people were diagnosed with acute promyelocytic leukemia (APL).
- people have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).
- people developed secondary AML after previous antitumor therapy for other tumors (except MDS, MDS/MPN).
- people had CNS leukemia with associated clinical symptoms.
See the full eligibility criteria
Who can join
- To be enrolled in this study, people must meet all of the following .
- Voluntary signing of ICF.
- Age ≥ 18 years old.
- Expected survival \>12 weeks.
- Dose escalation component: Advanced primary AML or myelodysplastic neoplasm (MDS) secondary to AML or MDS/myeloproliferative neoplasm (MPN)-associated AML (AML-MR) diagnosed by 2022 WHO AML typing and with diagnostic...
- ECOG scores physical fitness status 0 to 2.
- people are willing to undergo a bone marrow aspiration/biopsy as required by the protocol, which is used to assess the subject's response to treatment.
- Laboratory test index requirements within 7 days prior to the first dose, including: White blood cell count (WBC) ≤ 20 x 109 /L [(hydroxyurea is allowed up to the first dose to stabilize the WBC count up to a maximum...
- Residual toxicity of previous antitumor therapy ≤ grade 1 (except alopecia and hyperpigmentation; see 7 for laboratory test indices)
- Be willing and able to comply with the study schedule and all other study protocol requirements.
- Women of childbearing potential (WOCBP) (women of childless potential defined as sexually mature women who have undergone hysterectomy or bilateral oophorectomy or bilateral salpingo-oophorectomy or bilateral tubal...
- Female people of childbearing potential and male people whose partners are of childbearing potential must use a highly effective method of contraception from the time of screening until 180 days after the last treatment.
- people are required to provide FLT3 mutation status testing within 6 months prior to the first dose, and if not, are willing to undergo screening period testing as required by the protocol.
What rules you out
- To be enrolled in this study, people must not meet any of the following exclusion criteria.
- Known hypersensitivity to any component of the study drug formulation.
- people were diagnosed with acute promyelocytic leukemia (APL).
- people have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).
- people developed secondary AML after previous antitumor therapy for other tumors (except MDS, MDS/MPN).
- people had CNS leukemia with associated clinical symptoms.
- Enrolled in any therapeutic clinical study within 28 days prior to the first dose and enrolled in treatment, except in the survival follow-up phase of the treatment study.
- Received anti-tumor therapy (including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, etc.) within 28 days or 5 half-lives (whichever is shorter) prior to the first dose. Received radiotherapy within...
- ≥ Grade 2 graft-versus-host disease (GvHD), including acute, chronic or overlapping or escalating GvHD therapy within 14 days prior to first dose or being treated with systemic cortisol hormone for GvHD.
- Received chimeric antigen receptor T-cell immunotherapy (CAR-T) within 3 months prior to the first dose.
- Strong inducer or strong inhibitor of cytochrome P450 (CYP450) 2C8 or 3A4 enzymes taken within 14 days prior to the first dose, unless the investigator assesses that the drug is necessary for the subject's treatment...
- Major surgery within 28 days prior to first dose or minor surgery within 7 days prior to first dose, except diagnostic biopsy, insertion of vascular access device
- people have clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and vascular hemophilia.
- Intractable hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and with previous recurrent episodes.
- Active tuberculosis, or interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, history of radiation pneumonia, or clinically active interstitial lung disease as suggested by...
- Presence of an uncontrolled active infection (defined as exhibiting persistent signs/symptoms associated with the infection that do not improve despite appropriate antibiotic or other treatment) within 72 hours prior to...
- Inability to take oral medication, history of previous surgery or severe gastrointestinal disorders such as dysphagia and active gastric ulcer, which the investigator believes may affect the absorption of the study drug.
- History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (other than thrombosis due to vascular access devices or superficial venous thrombosis) within 3 months prior to the first dose.
- Active or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV-DNA titers), HCV (HCV-Ab positive with positive HCV-RNA titers), HIV positive.
- History of clinically significant cardiovascular disease, including.
- Congestive heart failure (NYHA classification ≥ Class III) within 6 months prior to first dose
- Unstable angina occurred within 6 months prior to the first dose.
- Myocardial infarction within 6 months prior to the first dose.
- Presence of poorly controlled arrhythmias at screening (e.g., people with ventricular tachycardia occurring during antiarrhythmic drug therapy will be excluded; however, people with atrioventricular block of degree I or...
- Diagnosis or suspicion of long QT syndrome at screening (including a family history of long QT syndrome)
- QTcF interval \>450 msec (using the Fridericia formula).
- Left ventricular ejection fraction (LVEF) \<45%.
- Uncontrolled hypertension (on the basis of lifestyle improvement, blood pressure has not reached the standard after applying a reasonably tolerable adequate dose of 2 or more antihypertensive drugs for more than 1...
- Stroke, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose.
- Pregnant or lactating women.
- Any active serious mental illness, medical condition or other symptom/condition that, in the judgment of the investigator, may interfere with treatment, compliance or the ability to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.