A Study of EP0031 in Patients With Advanced RET-altered Malignancies

Eligibility Criteria

• 1. Must be ≥18 years of age, with documented RET-altered cancers
• 2. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
• 3. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
• 4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
• 5. Additional cohort specific criteria apply
• 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 medication
• 4. Severe or uncontrolled medical condition or psychiatric condition
• 5. Chronic glomerulonephritis or renal transplant
• 6. Patients with active hepatitis B infection or active hepatitis C
• 7. 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
• 8. Receipt of any strong inhibitor or inducer of CYP3A4
• 9. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
• 10. 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
• 11. Uncontrolled hypertension
• 12. Corneal ulceration at screening