Kbi-092 < CERTIFIED · 2026 >

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).

By inhibiting both FLT3 and IRAK4 simultaneously, KBI-092 aims to overcome the "bypass mechanisms" cancer cells use to survive when only one pathway is blocked. KBI-092

The development of KBI-092 involves high-level collaboration within the biopharmaceutical ecosystem. , a leading global Contract Development and Manufacturing Organization (CDMO) , is frequently involved in scaling the production of complex biologics and small molecules for clinical trials. This open-label study is designed to assess the

Unlike traditional therapies that target a single pathway, KBI-092 is engineered for a "two-pronged" attack on leukemia cells. Its therapeutic efficacy stems from the selective inhibition of two critical proteins: Its therapeutic efficacy stems from the selective inhibition

They provide the necessary infrastructure—including mammalian and microbial expression systems —to ensure that experimental compounds like KBI-092 meet strict GMP (Good Manufacturing Practice) standards for human testing. Description Primary Code Drug Class Small molecule antineoplastic; Dual Kinase Inhibitor Targets FLT3 and IRAK4 Primary Indication Relapsed/Refractory Acute Myeloid Leukemia (RR-AML) Administration Oral tablet, twice daily (BID) Trial Phase Phase 1 (First-in-Human)

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.