Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Advanced Solid Tumor, selective RET-inhibitor, Neoplasms, RET fusion-positive NSCLC, RET mutation-positive MTC, Other RET-altered solid tumours

Eligibility

You can join if…

Open to people ages 18 years and up

Applicable to all patients:

  1. Must be ≥18 years of age at the time of informed consent, with documented RET-altered malignancy
  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 at screening
  4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures

You CAN'T join if...

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

Locations

  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States
  • Providence Portland Medical Centre accepting new patients
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ellipses Pharma
ID
NCT05443126
Phase
Phase 1/2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 265 study participants
Last Updated