RecruitingPhase 1Phase 2NCT05443126

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

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

Sponsor

Ellipses Pharma

Enrollment

265 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

NSCLC

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called EP0031, a drug called Pemetrexed, and others for people with nsclc. The study is currently recruiting participants at 52 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEP0031

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

DRUGPlatinum 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.

DRUGPemetrexed

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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05443126

Related Trials

Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

NCT073973386 locations

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

NCT0352683554 locations

The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer

NCT067381601 location

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

NCT06881784152 locations

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

NCT06422143215 locations