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

April 18, 2024 updated by: Ellipses Pharma

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

265

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
      • Madrid, Spain, 28034
      • Madrid, Spain, 28050
      • Madrid, Spain, 28041
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Virgen de la Victoria de Malaga
        • Contact:
  • United Kingdom
      • London, United Kingdom, NW1 2BU
      • London, United Kingdom, SE1 9RT
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust - Christie Hospital
        • Contact:
      • Sheffield, United Kingdom, S10 2JF
  • United States
    • California
      • Los Angeles, California, United States, 90095
      • Stanford, California, United States, 94305
    • District of Columbia
    • Florida
      • Fort Myers, Florida, United States, 33908
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Evanston, Illinois, United States, 60208
    • Kentucky
      • Lexington, Kentucky, United States, 40506
    • Michigan
      • Detroit, Michigan, United States, 48201
    • New York
    • Oregon
      • Portland, Oregon, United States, 97213
    • Tennessee
    • Texas
      • Houston, Texas, United States, 77030
    • Washington
      • Seattle, Washington, United States, 63130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RET fusion-positive NSCLC
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Experimental: RET mutation-positive MTC
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Experimental: Other RET-altered solid tumours
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Experimental: RET fusion-positive NSCLC (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Experimental: RET mutation-positive MTC (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Experimental: Other RET-altered solid tumours (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
Drug: EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment
Time Frame: First 28 days of treatment
First 28 days of treatment
Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC)
Time Frame: First 48 hours after drug administered
To characterise the pharmacokinetics (PK) of EP0031
First 48 hours after drug administered
Maximum Plasma Concentration (Cmax)
Time Frame: First 24 hours after drug administered
To characterise the pharmacokinetics (PK) of EP0031
First 24 hours after drug administered
Time taken for drug concentration to fall from half its original value (Half-life)
Time Frame: First 72 hours after drug administered
To characterise the pharmacokinetics (PK) of EP0031
First 72 hours after drug administered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellipses Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP0031-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Solid Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe