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

NCT07137637 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-22

No results posted yet for this study

Summary

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.

Conditions

  • Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)

Interventions

DRUG

HPB-092 tablet

HPB-092 is formulated as a tablet for oral administration, taken twice daily (BID) over consecutive 28-day cycles. This novel small molecule selectively inhibits both FLT3 and interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 plays a crucial role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in acute myeloid leukemia (AML) and other malignancies.

Sponsors & Collaborators

  • Hangzhou Polymed Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jianxiang Wang, MD · Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-09-14
Completion
2027-12-14
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137637 on ClinicalTrials.gov