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

Studio Clinico

Patologia: Neoplasie del polmone, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, II

Linee di trattamento: Prima linea, Seconda linea

Criteri di inclusione: 

Applicable to all patients:

- 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.

Criteri di esclusione: 

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.

Trattamento sperimentale: 

EP0031

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-501636-42-00

Data di inserimento: 23.06.2026

Promotore

Ellipses Pharma

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -