HPB-092 for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Diagnoza potwierdzonych zaawansowanych form białaczki mieloidalnej (choroba nawrotowa lub odporna na leczenie)
- •Wiek 18 lat lub więcej
- •Oczekiwana długość życia co najmniej 12 tygodni
- •Funkcja nerek: kreatynina w normie lub clearance ≥ 60 mL/min
- •Funkcja wątroby: bilirubina i enzymy hepatyczne w normie lub nieznacznie podwyższone
- •Funkcja serca: wyrzutność lewej komory powyżej 50%
- •Pacjent nie kwalifikuje się do innych skutecznych terapii
- •Kobieta musi być w wieku poprodukcyjnym lub stosować antykoncepcję
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Institute of Hematology and Blood Diseases Hospital, Tianjin, China
Tianjin, China
Trial contact
YONG GUO, MD
He Zhou, MD/PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/24/2026.
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