Condition: Relapsed and Refractory Acute Myeloid Leukemia (RR-AML) · Sponsor: Hangzhou Polymed Biopharmaceuticals, Inc.
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.
This description comes directly from the study's public registry record.
YONG GUO, MD · +8613480793536 · yong.guo@polymedbiopharma.com
He Zhou, MD/PhD · he.zhou@polymedbiopharma.com
Always discuss trial participation with your own doctor first.
| Institute of Hematology and Blood Diseases Hospital, Tianjin, China | Tianjin, China | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07137637