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 Modular, Open-label, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies

    Cancer Categories
    • Gastrointestinal (GI),Head and Neck,Lung
    Karmanos Trial ID
    • 2023-066
    NCT ID
    • NCT05443126
    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


    Module A Monotherapy—dose escalation

    Primary Objective:

    • To investigate the safety and tolerability of EP0031 given as monotherapy

    Secondary Objective:

    • To characterize the PK of EP0031 given as monotherapy, after a single dose and at steady state after multiple dosing

    Modules B and C Monotherapy—dose expansion

    Primary Objective:

    • To assess the efficacy of EP0031 given as monotherapy in patients with RET-altered tumours who have progressed following firstgeneration SRI therapy and in patients with RET-altered tumors with no prior SRI therapy (by RECIST v1.1)

    Secondary Objectives:

    • To investigate the safety and tolerability of EP0031 given as monotherapy
    • To characterize the PK of EP0031 given as monotherapy
  • 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