[upd] — Kbi-092

This open-label study is designed to assess the safety, tolerability, and pharmacokinetics of the drug. It typically begins with a dose of 30 mg twice daily (BID), escalating up to 200 mg BID to determine the Recommended Phase 2 Dose (RP2D).

The drug has received clearance from both the FDA (United States) and the NMPA (China) to begin Phase 1 clinical trials. KBI-092

Mutations in the FLT3 gene are among the most common genetic alterations in AML. These mutations cause the FLT3 receptor to stay "on" permanently, sending constant growth and survival signals to leukemia cells. This open-label study is designed to assess the

The trial focuses on patients with relapsed/refractory AML, especially those with specific mutations like FLT3 , U2AF1 , or SF3B1 , which are known to drive IRAK4 activity. Pharmaceutical Manufacturing & Development Mutations in the FLT3 gene are among the