A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
ConditionAML, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang ACEA Pharmaceutical Co. Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 criteria that have failed standard therapy or are intolerant of standard therapy may be considered for inclusion in this component of the study. Dose extension section: Advanced primary AML or MDS secondary to AML or AML-MR diagnosed according to the 2022 WHO AML typing and associated diagnostic criteria, who have failed or are intolerant to standard therapy, or who are unable to access standard therapy for various reasons, may only be considered for inclusion in this part of the study.
Disqualifiers
Known hypersensitivity to any component of the study drug formulation.
Subjects were diagnosed with acute promyelocytic leukemia (APL).
Subjects have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).
Subjects developed secondary AML after previous antitumor therapy for other tumors (except MDS, MDS/MPN).
Trial design
Design model
Single group
Treatments tested in this trial
STI-8591
DrugFour dosing cohorts will be evaluated in the dose escalation phase: 20mg, 40mg, 60mg and 80mg. Expansion is planned in two dose groups of 40mg and 60mg.
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: STI-8591 in Advanced Acute Myeloid Leukemia (AML)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)
Time frame
Up to 3 years.Secondary outcomes
1
Assessment of the AUC of STI-8591 and its major metabolites (if any).
Assessment of the pharmacokinetic profile of STI-8591 and its major metabolites (if any) in advanced AML:AUC(area under the concentration-time curve)
Time frame
At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .2
Assessment of the Tmax of STI-8591 and its major metabolites (if any).
Assessment of the pharmacokinetic profile of STI-8591 and its major metabolites (if any) in advanced AML:Tmax (time to peak)
Time frame
At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .3
Assessment of the Cmax of STI-8591 and its major metabolites (if any).
Assessment of the pharmacokinetic profile of STI-8591 and its major metabolites (if any) in advanced AML:Cmax(peak concentration)
Time frame
At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .4
Percentage change in FLT3 plasma inhibitory activity (PIA) relative to baseline
Assessment of the percentage of biomarker changes relative to baseline for STI-8591 in advanced AML
Time frame
At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .Sponsors and contacts
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Source ClinicalTrials.gov