Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Ellipses Pharma (Voir sur ClinicalTrials)
septembre 2022
juin 2027
02 mars 2026
The aim of this study is to assess the safety, side effects and effectiveness of EP0031
in patients with advanced RET-altered malignancies (NSCLC)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 28/07/2026 08:35:05 | Contacter | ||
Critères
Tous
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