RecruitingPhase 1Phase 2NCT05443126
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
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
Sponsor
Ellipses Pharma
Enrollment
265 participants
Start Date
Sep 30, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies (NSCLC)
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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
Exclusion Criteria13
- 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
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Interventions
DRUGEP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT05443126
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