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

Study Identifier:
EP0031-101
CT.gov Identifier:
NCT05443126
EudraCT Identifier:
202200000000
EU Trial (CTIS) Number:
2022-501636-42-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered thyroid and non-small cell lung cancer including patients who have not received prior treatment with first generation SRIs.

To evaluate whether EP0031, an orally available next generation SRI, can address resistance to 1st generation SRIs and improve on their clinical profile.

To investigate safety, tolerability, PK and PD and to define the maximum tolerated dose (MTD) and/or Recommended Phase II Dose (RP2D).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Non-Small Cell Lung Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: RET fusion-positive NSCLC (prior 1st gen SRI)
    • Read More
  • Drug: Experimental: RET mutation-positive MTC (prior 1st gen SRI)
  • Drug: Experimental: Other RET-altered solid tumours (prior 1st gen SRI)
  • Drug: Experimental: RET fusion-positive NSCLC (no prior SRI therapy)
  • Drug: Experimental: RET mutation-positive MTC (no prior SRI therapy)
  • Drug: Experimental: Other RET-altered solid tumours (no prior SRI therapy)
  • Drug: Patients are dosed between 40 and 120mg OD
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Must be ≥18 years of age, with documented RET-altered cancers
    • Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
    • ECOG performance status of 0 or 1 and life expectancy >3 months at screening
    • Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
    • Additional cohort specific criteria apply
    Exclusion criteria
    • Patients with any of the following will not be included in the study:
    • Any known major driver gene alterations other than RET.
    • Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
    • Active infection requiring systemic antibiotic, antifungal, or antiviral medication
    • Severe or uncontrolled medical condition or psychiatric condition
    • Chronic glomerulonephritis or renal transplant
    • Patients with active hepatitis B infection or active hepatitis C
    • Patients with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months
    • Receipt of any strong inhibitor or inducer of CYP3A4
    • Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
    • Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade II-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months
    • Uncontrolled hypertension
    • Corneal ulceration at screening

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer