A Study of EP0031 in Patients With Advanced RET-altered Malignancies
Trial ID or NCT#
NCT05443126
Status
RECRUITING
Purpose
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- Applicable to all patients:
- 1. Must be ≥18 years of age, with documented RET-altered cancers2. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies3. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures5. Additional cohort specific criteria apply
Exclusion Criteria:
- Patients with any of the following will not be included in the study:
- 1. Any known major driver gene alterations other than RET.2. Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.3. Active infection requiring systemic antibiotic, antifungal, or antiviral medication4. Severe or uncontrolled medical condition or psychiatric condition5. Chronic glomerulonephritis or renal transplant6. Patients with active hepatitis B infection or active hepatitis C7. 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 months8. Receipt of any strong inhibitor or inducer of CYP3A49. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function10. 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 months11. Uncontrolled hypertension12. Corneal ulceration at screening
Investigator(s)
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Contact
Emmanuel Ifeanyi Ugwu
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