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Testing EP0031 for advanced RET-altered cancers

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

Phase1; Phase2 Interventional Ellipses Pharma · NCT05443126

This study is testing a new drug called EP0031 to see if it can help people with advanced cancers that have specific genetic changes and who haven't responded well to previous treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment265 (estimated)
Ages18 Years and up
SexAll
SponsorEllipses Pharma Industry-sponsored
Locations40 sites (Los Angeles, California and 39 other locations)
Trial IDNCT05443126 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with documented RET-altered cancers and an ECOG performance status of 0 or 1.

Not a fit: Patients with major driver gene alterations other than RET or those with severe uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced RET-altered cancers who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with selective RET inhibitors, but this specific approach with EP0031 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Where this trial is running

Los Angeles, California and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorNSCLCselective RET-inhibitorRET
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.