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

Launched by ELLIPSES PHARMA · Jul 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EP0031 for patients with advanced solid tumors that have a specific genetic change known as RET alteration. The main goal of the study is to find out how safe the treatment is, what side effects it might cause, and how effective it is in fighting these types of cancers. The trial is currently looking for participants, and anyone aged 18 or older with a confirmed RET-altered malignancy may be eligible to join, as long as they are in relatively good health and can understand and agree to the study procedures.

If you decide to participate, you will be closely monitored throughout the trial to ensure your safety and well-being. It’s important to note that some individuals may not qualify, particularly those with other significant health issues or certain medical conditions, such as severe infections or uncontrolled heart problems. This study offers a new option for patients whose current treatment may not be working, and it encourages participants to discuss all available treatment choices with their healthcare team before deciding to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Applicable to all patients:
• • 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
• 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 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