Testing EP0031 for advanced RET-altered cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety, side effects, and effectiveness of EP0031, a selective RET inhibitor, in patients with advanced RET-altered malignancies. It is a modular, interventional Phase I/II study that includes dose escalation and optimization to determine the optimal dose for treatment. The study aims to provide an alternative for patients who have progressed on first-generation selective RET inhibitors, as EP0031 is designed to overcome resistance mechanisms associated with these earlier therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Applicable to all participants:

1. Must be ≥18 years of age, with documented RET-altered NSCLC
2. Participants 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. Measurable disease defined by RECIST v1.1
6. Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive platinum-based doublet chemotherapy.
7. First line patients: Must not have received a Selective RET inhibitor or chemotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior. Palliative radiotherapy for symptom management (eg, bone metastases) is permitted up to 2 weeks prior to treatment start.

Exclusion Criteria:

Participants 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. Participants with active hepatitis B infection or active hepatitis C
7. Participants 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 III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months
11. Uncontrolled hypertension
12. Corneal ulceration or untreated keratitis at screening

Where it's running

• David Geffen School of Medicine at UCLA
  Los Angeles, California, United States Recruiting
• Stanford University
  Stanford, California, United States Recruiting
• Georgetown University
  Washington D.C., District of Columbia, United States Recruiting
• University of Miami - Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Florida Cancer Specialists & Research Institute
  West Palm Beach, Florida, United States Recruiting
• Northwestern University
  Evanston, Illinois, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Team
• Email: Enquires@ellipses.life
• Phone: +44 20 3743 0992

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.