EICHORCondition: AML, Adult · Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.
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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.
This description comes directly from the study's public registry record.
Jie Jin, Doctor · 0571-87236896 · jiej0503@163.com
Always discuss trial participation with your own doctor first.
| the First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou, Zhejiang, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05947344