Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Phase 1/2a, Open-Label Dose Escalation and Cohort Expansion Study of Orally Administered CA-4948 (IRAK4i) as a Monotherapy in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2023-095
    NCT ID
    • NCT04278768
    Age Group
    • Adult
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Jay
      Yang, M.D.

      Oncology - Hematology, Oncology - Medical View Profile


    Phase 1 Dose Escalation

    Primary Objectives:

    • To evaluate the safety and tolerability of CA-4948 in patients with R/R AML and
    • To identify the MTD and RP2D

    Secondary Objectives:

    • To characterize the PK parameters of CA-4948 using non-compartmental analysis
      and appropriate PK modelling
    • To assess anti-cancer activity

    Phase 2a Dose Expansion

    Primary Objective:

    • To assess anti-cancer activity of CA-4948 at RP2D in patients with R/R AML with
      FLT-3 mutations, and patients with R/R hrMDS or R/R AML with spliceosome
      mutations of SF3B1 or U2AF1

    Secondary Objectives:

    • To assess tolerability and long-term safety
    • To further assess anti-cancer activity of CA-4948 at RP2D
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266