A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
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.