A Study of EP0031 in Patients With Advanced RET-altered Malignancies

Sponsor: Ellipses Pharma

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05443126

Patient View

This Phase I/II study evaluates EP0031, a selective RET inhibitor, for safety and efficacy in adults with advanced RET-altered malignancies. Eligible patients must be ≥18, with documented RET alterations and ECOG 0-1. Exclusions include other major gene alterations, active infections, and certain medical conditions. EP0031 aims to overcome resistance to first-generation SRIs.

Patient Parameters

Program Overview

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies

Description

EP0031 is being investigated in this modular, interventional Phase I/II dose escalation and dose expansion study to investigate the optimal dose in adult patients with advanced RET-altered malignancies. Currently there are no approved RET-targeted treatments for patients who progress on first-generation SRIs. However, it is proposed that EP0031 can overcome resistance mechanisms to first generation SRIs, as EP0031 is a potent and selective RET inhibitor with broad activity against common RET fusions and mutations. Phase I (dose escalation and optimization) has completed and a RP2D has been selected for Phase II.

Eligibility 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

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