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A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies

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Trial Profile

A Phase I/IIa, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 Single Agent and in Combination With Venetoclax and Azacitidine in Patients With Relapsed/Refractory Hematologic Malignancies

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 May 2024

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At a glance

  • Drugs SLS 009 (Primary) ; Azacitidine; Venetoclax
  • Indications Acute myeloid leukaemia; Chronic lymphocytic leukaemia; Haematological malignancies; Lymphoma
  • Focus Adverse reactions; First in man
  • Sponsors GenFleet Therapeutics
  • Most Recent Events

    • 01 May 2024 According to a Sellas Life Sciences Group media release, Joshua Zeidner, MD, Associate Professor of Medicine, Chief of Leukemia Research, Associate Chief of Research in the Division of Hematology, Director of Clinical Cancer Research Commercial Integration at the University of North Carolina Lineberger Comprehensive Cancer Center is the principal investigator of this trial.
    • 01 May 2024 According to a Sellas Life Sciences Group media release, compelling results from this trial will further support for potential Accelerated Approval Pathway in defined patient population. The company intends to initiate discussions with the U.S. Food and Drug Administration (FDA) about the potential for an accelerated approval pathway with SLS009 in the ASXL1 molecularly defined r/r AML population as well as in patients harboring this mutation in other indications.
    • 01 May 2024 According to a Sellas Life Sciences Group media release, study enrollment ongoing at 30mg BIW Dose of SLS009 with Expansion Cohort of ASXL1 Mutation patients and updates expected in Q3 2024. As of April 19, 2024 data cutoff, a 57% overall response rate has been achieved thus far, in the selected optimal dose regimen of 30 mg BIW, far surpassing the targeted 20% rate.
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