HPB-092 for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia

HPB-092 effectively inhibits Fms-like tyrosine kinase 3 (FLT3) mutants with comparable or superior potency to approved FLT3 inhibitors and demonstrates improved selectivity, potentially reducing toxicity. Its highly selective and potent inhibition of Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) may provide additional therapeutic benefits that could enhance treatment efficacy and durability for patients with relapsed or refractory acute myeloid leukemia (RR-AML), further improving clinical outcomes in this population. HPB-092 also has a favorable safety profile, with no major risks identified in preclinical studies. Phas 1 Study Outline: 1. This is a multicenter, open-label, phase 1 study to evaluate the safety and efficacy of oral HPB-092 as monotherapy in patients with RR-AML. 2. The study aims to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy. 3. It consists of two parts: Part A for dose escalation and Part B for dose expansion, involving single or multiple doses. 4. Patients must be diagnosed with morphologically documented RR-AML according to World Health Organization (WHO) 2022 criteria. 5. Baseline assessments will include RR-AML with FLT3 mutations, spliceosome mutations in SF3B1 and U2AF1, as well as other biomarkers, which will be monitored throughout the study.

NCT Number	NCT07137637
Lead Sponsor	Hangzhou Polymed Biopharmaceuticals, Inc.
Conditions	Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)
Enrollment	60 participants
Start Date	2026-04-10
Primary Completion	2027-06 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-23