EP0031-101: A Study of EP0031 in Patients with Advanced RET-Altered Malignancies

Clinical Trial Title

EP0031-101: 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

National Clinical Trial Number:

NCT05443126

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Protocol Description:

The purpose of this study is to investigate whether a new investigational treatment, EP0031, will be a safe and possibly effective treatment option for individuals with RET-altered solid tumors. The study is designed to find a safe and effective dose of EP0031. EP0031 is an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.

The study drug is given in repeating 28-day periods called cycles. You will take EP0031 orally (by mouth) once per day of each 28 day cycle. During each cycle, you will have tests and procedures. Most of these are part of regular care for your type of cancer. Some tests and procedures will be needed more often than normal because you are in this study. There will also be additional tests and procedures that are specific to this study to minimize risks and to provide information on how the study drug works on your tumor.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are ≥18 years of age at the time of informed consent, with documented RET-altered malignancy.
  • Have an ECOG performance status of 0 or 1 at screening.

You will be excluded from the study if any of the following criteria apply to you:

  • Have any known major driver gene alterations other than RET.
  • Have spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
  • Have received any strong inhibitor or inducer of CYP3A4.
  • Have uncontrolled hypertension.
  • Have corneal ulceration at screening.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Michael Jelinek, MD

Contact Information

Rush Cancer Center Clinical Trials Office

Clinical Trial Location

RUSH University Medical Center

Location

RUSH University Medical Center

1620 W Harrison St
Chicago, IL 60612

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