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December 8, 2025Blood

Phase 1/2, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, and efficacy of Zefamenib combined with chemotherapy or targeted Agents in patients with Acute Myeloid Leukemia

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Authors

HDHaiping DaiDWDepei WuSCSuning Chen

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Implication

Phase 1/2 trial assesses safety and efficacy of zefamenib combined with chemotherapy or venetoclax in AML, suggesting a potential new treatment avenue.

Key Points

  • This research aims to evaluate the safety, pharmacokinetics, and efficacy of zefamenib in combination with chemotherapy or targeted agents in AML patients.
  • Phase 1/2, multicenter, open-label clinical study
  • 90 patients enrolled in phase 1 for safety and tolerance assessment
  • 30-45 patients in phase 2 for efficacy evaluation
  • Overall response rate of 89.3% with zefamenib in specific mutation patients
  • Complete remission rates and safety demonstrated with zefamenib and venetoclax
  • No dose-limiting toxicity reported during the trial

Cite This Study

Dai et al. (2025) studied this question.

synapsesocial.com/papers/69362f714fa91c937236e17ehttps://doi.org/10.1182/blood-2025-8257
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-0072025 · 8 citations
  2. 2Ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia: Phase 1b results from KOMET-0072025 · 13 citations
  3. 3Ziftomenib with venetoclax and azacitidine in relapsed/refractory NPM1-mutated acute myeloid leukemia2026 · 2 citations
  4. 4Preliminary data from the ongoing Phase 1 study of the menin-MLL inhibitor enzomenib (DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory Acute Myeloid Leukemia2025 · 7 citations
  5. 5Ziftomenib in Relapsed or Refractory <i>NPM1</i> -Mutated AML2025 · 40 citations