Suzhou-based Ascentage Pharma (HKG: 6855) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a first-in-human clinical study of its embryonic ectoderm development (EED) inhibitor APG-5918. The study will assess the safety, pharmacokinetics, and preliminary efficacy of the drug in patients with advanced solid tumors or hematological malignancies. The primary investigator will be Dr. Joseph Paul Eder, clinical director of Yale Cancer Center’s early drug development program.
Study Design
The global multi-center, open Phase I clinical study is designed to evaluate the safety and tolerability of APG-5918 and determine its dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D).
Drug Profile
APG-5918 is an investigational, oral, potent, and selective small-molecule EED inhibitor with high affinity. As an allosteric inhibitor, it can selectively bind to EED proteins and is expected to overcome tumor resistance while achieving complete and durable tumor regression by modulating tumor epigenetics and the tumor microenvironment.-Fineline Info & Tech
