Spots Global Cancer Trial Database for A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
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Trial Identification
Brief Title: A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
Official Title: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types
Study ID: NCT04300556
Conditions
Study Description
Brief Summary: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \[OC\], endometrial cancer \[EC\], non-small cell lung carcinoma \[NSCLC\], triple-negative breast cancer \[TNBC\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[EC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Center - Hunt - PPDS, Tucson, Arizona, United States
University of Arkansas For Medical Sciences, Little Rock, Arkansas, United States
Stanford University School of Medicine, Stanford, California, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Orchard Healthcare Research Inc, Skokie, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States
Barbara Ann Karmanos Cancer Institute, New Brunswick, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Texas MD Anderson Cancer Centre, Houston, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer, Nice, Alpes-Maritimes, France
ICANS - Institut de cancérologie Strasbourg Europe, Strasbourg, Bas-Rhin, France
Institut Paoli Calmettes, Marseille, Bouches-du-Rhone, France
Hopitaux de La Timone, Marseille, Bouches-du-Rhône, France
Centre François Baclesse, Caen, Calvados, France
Clinique Amoricaine de Radiologie, Saint-Brieuc, Cote-d'Amore, France
EDOG Institut de Cancerologie de l'Ouest - PPDS, Nantes, Loire-Atlantique, France
Clinique Catherine de Sienne, Nantes, Loire-Atlantique, France
Centre Oscar Lambret, Lille, Nord, France
Centre Hospitalier de la Cote Basque, Bayonne, Pyrenees-Atlantiques, France
Centre Leon Berard Centre Regional de Lutte Contre, Lyon, Rhone, France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes, Lyon, Rhône, France
CLCC - Gustave Roussy Cancer, Villejuif, Val-de-Marne, France
Hôpital de la Croix Saint-Simon, Paris, , France
Hopital Cochin, Paris, , France
ICO Badalona-H.U. Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Clinica Universidad Navarra - Madrid, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario de Toledo, Toledo, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Belfasr City Hospital, Belfast, Antrim, United Kingdom
Lancashire Clinical Research Facility, Royal Preston Hospital, Preston, Lancashire, United Kingdom
Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom
Velindre Cancer Centre - PPDS, Cardiff, South Glamorgan, United Kingdom
The Royal Marsden, Sutton, Surrey, United Kingdom
Beatson West of Scotland Cancer Centre - PPDS, Glasgow, , United Kingdom
Guys and St Thomas's Hospital, London, , United Kingdom
The Christie NHS Foundation Trust - PPDS, Manchester, , United Kingdom
Contact Details
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