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
Qualifiers
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
Treatments tested in this trial
- STI-8591
Treatment groups
84 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov