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December 8, 2025BloodOpen Access

Phase 1b study of HC-7366 alone and in combination with venetoclax and azacitidine in relapsed/refractory Acute Myeloid Leukemia

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Authors

NDNaval DaverOBOscar BenitezDMDavid McCue

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Overview

Phase 1b study shows HC-7366 improves outcomes in relapsed/refractory AML with TP53 mutations, indicating potential for overcoming resistance.

Key Points

  • To evaluate the safety and efficacy of HC-7366 as monotherapy and in combination with venetoclax and azacitidine in patients with relapsed/refractory AML.
  • Open-label phase 1b study design
  • Two treatment arms: HC-7366 monotherapy and HC-7366 with venetoclax and azacitidine
  • Dose escalation based on Bayesian Optimal Interval design
  • Eligibility includes adults with relapsed/refractory AML or MDS/AML
  • Primary focus on safety and dose-limiting toxicities
  • Preclinical studies show efficacy of HC-7366 in AML xenograft models
  • Combination therapy addresses multiple mechanisms of venetoclax resistance
  • FDA Fast Track designation received for HC-7366 treatment of R/R AML
  • Current enrollment for monotherapy and triplet combination ongoing
  • Promising results indicated for patients with TP53 mutations

Cite This Study

Daver et al. (2025) studied this question.

synapsesocial.com/papers/69362f7d4fa91c937236e50ahttps://doi.org/10.1182/blood-2025-1653
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Also Consider

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

  1. 15 A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Patients with Advanced or Metastatic Renal Cell Carcinoma, NCT062346052024 · 1 citations
  2. 2A phase 1b, open-label, safety, tolerability, and efficacy study of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic renal cell carcinoma.2026
  3. 3A phase 1/1b open-label, dose escalation, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-leukemic activity of the orally available clk inhibitor, BH-30236, in adults with R/R AML or HR-MDS2025
  4. 4Venetoclax in the treatment of acute myeloid leukemia: Beyond <scp>VIALE‐A</scp>2024 · 3 citations
  5. 5Pharmacokinetics and pharmacodynamics of the GCN2 activator HC-7366 in a phase 1a study in patients with advanced solid tumors.2026