RECRUITING

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

Conditions

Advanced Solid Tumor NSCLC selective RET-inhibitor RET

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-09-30

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05443126

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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	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

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Study Contact

Sonia Serrano

CONTACT

+44 (0)20 3743 0992

sonia@ellipses.life

Arturo Maldonado

CONTACT

+44 (0)20 3743 0992

arturo@ellipses.life

Study Locations (Sites)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

United States

Stanford University

Stanford, California, 94305

United States

Georgetown University

Washington D.C., District of Columbia, 20057

United States

Florida Cancer Specialist

Fort Myers, Florida, 33908

United States

RUSH University Medical Center

Chicago, Illinois, 60612

United States

Northwestern University

Evanston, Illinois, 60208

United States

University of Kentucky

Lexington, Kentucky, 40506

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Karmanos

Detroit, Michigan, 48201

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 07920

United States

NYU Langone Health

New York, New York, 10016

United States

Providence Portland Medical Centre

Portland, Oregon, 97213

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Sarah Cannon

Nashville, Tennessee, 37203

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Washington University

Seattle, Washington, 63130

United States

Seattle Cancer Care / Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2022-09-30

Study Completion Date2027-06

Study Record Updates

Study Start Date2022-09-30

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

selective RET-inhibitor
NSCLC
RET

Additional Relevant MeSH Terms

Advanced Solid Tumor
NSCLC