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RECRUITING

NCT05443126

PHASE1/PHASE2

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

Sponsor: Ellipses Pharma

View on ClinicalTrials.gov

Summary

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 (Lunbotinib) in patients with advanced RET-altered non-small cell lung cancer (NSCLC) in monotherapy and in combination with standard of care (SOC) chemotherapy.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

265

Start Date

2022-09-30

Completion Date

2028-03

Last Updated

2026-07-01

Healthy Volunteers

Conditions

NSCLC

Interventions

DRUG

EP0031

EP0031 is a potent next-generation selective RET-inhibitor (SRI)

DRUG

Platinum chemotherapy

One of either Cisplatin or Carboplatin. Both agents are potent platinum-based antineoplastic/alkylating agents administered as an IV infusion according to local practice and labels.

DRUG

Pemetrexed

Pemetrexed is a chemotherapy medication and antifolate metabolic inhibitor administered as an IV infusion according to local practice and labels.

Inclusion Criteria: Applicable to all participants: 1. Must be ≥18 years of age, with documented RET-altered NSCLC 2. Participants 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. Measurable disease defined by RECIST v1.1 6. Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive platinum-based doublet chemotherapy. 7. First line patients: Must not have received a Selective RET inhibitor or chemotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior. Palliative radiotherapy for symptom management (eg, bone metastases) is permitted up to 2 weeks prior to treatment start. Exclusion Criteria: Participants 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. Participants with active hepatitis B infection or active hepatitis C 7. Participants 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 III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months 11. Uncontrolled hypertension 12. Corneal ulceration or untreated keratitis at screening

Locations (52)

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Georgetown University

Washington D.C., District of Columbia, United States

Florida Cancer Specialist

Fort Myers, Florida, United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Florida Cancer Specialists & Research Institute

West Palm Beach, Florida, United States

RUSH University Medical Center

Chicago, Illinois, United States

Northwestern University

Evanston, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

NYU Langone Health

New York, New York, United States

The Ohio State University - Comprehensive Cancer Center

Columbus, Ohio, United States

Providence Portland Medical Centre

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Washington University - School of Medicine

Seattle, Washington, United States

University of Washington - Fred Hutchinson Cancer Center

Seattle, Washington, United States

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Léon Bérard

Lyon, France

Assistance Publique - Hôpitaux de Marseille

Marseille, France

Institut Gustave Roussy

Paris, France

Charité Comprehensive Cancer Center

Berlin, Germany

Universitätsklinikum Köln

Cologne, Germany

Ludwig-Maximilians-Universität München (LMU)

München, Germany

Centro di Riferimento Oncologico IRCCS

Aviano, Italy

IRCCSS AOU Bologna

Bologna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Torino, Italy

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

Warsaw, Poland

Hospital Universitario de A Coruña

A Coruña, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Madrid Sanchinarro

Madrid, Spain

Hospital Virgen de la Victoria de Malaga

Málaga, Spain

Tawam Hospital

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Sheik Shakhbout Medical City (SSMC)

Abu Dhabi, United Arab Emirates

Cleveland Clinic Abu Dhabi (CCAD)

Abu Dhabi, United Arab Emirates

University College London Hospital (UCLH)

London, United Kingdom

Guy's and St Thomas' Hospital NHSFT

London, United Kingdom

The Royal Marsden NHSFT

London, United Kingdom

The Christie Hospital NHSFT

Manchester, United Kingdom

Sheffield Teaching Hospitals NHSFT

Sheffield, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (52)