A Study of EP0031 in Patients With Advanced RET-altered Malignancies (NCT05443126) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
United States, France, Germany265 participantsStarted 2022-09-30
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment
Timeframe: First 28 days of treatment
2
Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1
. 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