RecruitingPhase 1NCT05947344

A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)

A Multicenter, Open, Dose Escalation and Dose Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)

Sponsor

Zhejiang ACEA Pharmaceutical Co. Ltd.

Enrollment

84 participants

Start Date

Dec 8, 2023

Study Type

INTERVENTIONAL

Conditions

AML, Adult

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new experimental drug called STI-8591 in people with advanced acute myeloid leukemia (AML) — a fast-moving blood cancer — that has not responded to or has relapsed after standard treatment. The study is testing the drug's safety and finding the right dose. **You may be eligible if...** - You are 18 or older with a life expectancy of more than 12 weeks - You have advanced AML (including certain AML subtypes) that has failed standard therapy, or you are unable to tolerate it - You are able to give voluntary informed consent **You may NOT be eligible if...** - Your overall health does not meet the required performance standards - You have significant organ dysfunction - You are currently taking conflicting medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTI-8591

Four 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.