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NCT05443126 | RECRUITING | Advanced Solid Tumor

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

Ellipses Pharma

Brief Summary:

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

Condition or disease

Advanced Solid Tumor

Intervention/treatment

EP0031

Phase

PHASE1

PHASE2

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. Phase I (dose escalation and optimization) has completed and a RP2D has been selected for Phase II.

Study Type : INTERVENTIONAL
Estimated Enrollment : 265 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-09-30
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study of EP0031 in Patients With Advanced RET-altered Malignancies

Location Details

NCT05443126

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

David Geffen School of Medicine at UCLA

Los Angeles, California, United States, 90095

RECRUITING

United States, California

Stanford University

Stanford, California, United States, 94305

RECRUITING

United States, District of Columbia

Georgetown University

Washington, District of Columbia, United States, 20057

RECRUITING

United States, Florida

Florida Cancer Specialist

Fort Myers, Florida, United States, 33908

RECRUITING

United States, Illinois

RUSH University Medical Center

Chicago, Illinois, United States, 60612

RECRUITING

United States, Illinois

Northwestern University

Evanston, Illinois, United States, 60208

RECRUITING

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40506

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Road cancer

Karmanos

Detroit, Road cancer, United States, 48201

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 07920

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Oregon

Providence Portland Medical Centre

Portland, Oregon, United States, 97213

RECRUITING

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Tennessee

Sarah Cannon

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

Viginia cancer specialists

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Washington

Washington University

Seattle, Washington, United States, 63130

RECRUITING

United States, Washington

Seattle Cancer Care / Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

RECRUITING

France, Bouches-du-Rhône

Public assistance - Marseille hospitals

Marseille, Bouches-du-Rhône, France,

RECRUITING

France, Gironde

Center Bergonié

Bordeaux, Gironde, France,

RECRUITING

France, Paris

Gustave-Roussy Institute

Villejuif, Paris, France,

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

Ramon and Cajal University Hospital

Madrid, Spain, 28034

RECRUITING

Spain,

University Hospital October 12

Madrid, Spain, 28041

RECRUITING

Spain,

Hospital Madrid Sanchinarro

Madrid, Spain, 28050

RECRUITING

Spain,

Virgen de la Victoria de Malaga hospital

Málaga, Spain, 29010

RECRUITING

United Arab Emirates, Abu Dhabi

Tawam Hospital

Where is, Abu Dhabi, United Arab Emirates,

NOT YET RECRUITING

United Arab Emirates,

Sheik Shakhbout Medical City (SSMC)

Abu Dhabi, United Arab Emirates, 11001

RECRUITING

United Arab Emirates,

Cleveland Chleveland Abu Dhabi (CCAD)

Abu Dhabi, United Arab Emirates, 112412

RECRUITING

United Kingdom,

University College London Hospital

London, United Kingdom, Nw1 2bu

RECRUITING

United Kingdom,

Guy's Hospital

London, United Kingdom, SE1 9RT

RECRUITING

United Kingdom,

The Royal Marsden NHS Foundation Trust

London, United Kingdom, Juice

RECRUITING

United Kingdom,

The Christie NHS Foundation Trust - Christie Hospital

Manchester, United Kingdom, M20 4BX

RECRUITING

United Kingdom,

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom, S10 2JF