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A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma
Sponsor: Corbus Pharmaceuticals Inc.
Summary
The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life. The main questions it asks are: * What proportion of participants respond to CRB-701 measured using scans (CT or MRI) * What medical problems do participants experience when taking CRB-701. Researchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease). Participants will: * Attend clinic every three weeks to receive infusions of CRB-701 or standard of care medicines until the cancer cannot be measured or is not controlled by the treatment they are receiving. * Have a CT or MRI every 6 weeks to measure the effect on their cancer * Complete questionnaires to assess their health status.
Official title: A Randomized, 2-Arm Study to Evaluate the Efficacy and Safety of CRB-701 Compared With Investigator's Choice of Capecitabine, Cetuximab, or Docetaxel in Participants With Recurrent or Metastatic Oropharyngeal Squamous Cell Carcinoma Previously Treated With Platinum-based Chemotherapy and a PD-(L)1 Inhibitor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2026-09-29
Completion Date
2029-03
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
CRB-701
CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)
capcitabine
1250 mg/m2 twice daily on days 1-14 of each 21-day cycle
Cetuximab (EGFR inhibitor)
400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks.
Docetaxel
75 mg/m2 as an IV infusion on day 1 of each 21-day cycle or 30 mg/m2 weekly to escalate to 40 mg/m2, if tolerated.
Locations (111)
Clearview Cancer Institute
Huntsville, Alabama, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California Los Angeles Westwood Cancer Center
Los Angeles, California, United States
Stanford Medicine - Cancer Center
Palo Alto, California, United States
Moores Cancer Center
San Diego, California, United States
UCSF Head and Neck Surgery Cancer Program
San Francisco, California, United States
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado
Colorado Springs, Colorado, United States
Yale School of Medicine
Newhaven, Connecticut, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
Florida Cancer Specialists and Research Institute
Orlando, Florida, United States
Moffitt Cancer Center Magnolia Campus
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Iowa Health Care Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
University of Louisville Health
Louisville, Kentucky, United States
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute - Wayne State University
Detroit, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Nebraska Cancer Specialists - Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States
Memorial Sloan Kettering
New York, New York, United States
Gabrail Cancer Center and Research Center
Canton, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center The Arthur G.James
Columbus, Ohio, United States
Penn-Medicine - Abramson Cancer Center University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
Prisma Health Cancer Institute Multidisciplinary Center
Greenville, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Oncology
Austin, Texas, United States
Texas Oncology
Dallas, Texas, United States
UVA Health - Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center Clinical - Seattle Cancer Care Alliance
Seattle, Washington, United States
Northwest Cancer Center
Vancouver, Washington, United States
University Hospital Vienna
Vienna, State of Vienna, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
University Hospital Vienna
Vienna, Austria
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven Gasthuisberg Campus
Leuven, Belgium
Vitaz - Sint-Niklaas Moerland
Sint-Niklaas, Belgium
Cliniques Universitaires Saint-Luc - Centre du Cancer
Woluwe-Saint-Lambert, Belgium
Cross Cancer Institute
Edmonton, Canada
Verspeeten Family Cancer Centre
London, Canada
Jewish General Hospital
Montreal, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Canada
Allan Blair Cancer Centre
Regina, Canada
Institution: Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
Saint-Herblain, Saint Herblain, France
ICM - Institut du Cancer de Montpellier
Montpellier, Sevilla, France
Institut Curie
Paris, Sevilla, France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
Bordeaux, France
Centre Georges François Leclerc
Dijon, France
UNICANCER-Centre Leon-Berard (CLB)
Lyon, France
Hopitaux de Marseille AP-HM - Hopital de La Timone
Marseille, France
Universitätsklinikum Köln - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Cologne, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Universitaetsklinikum Muenster (UKM) - Klinik fuer Hals, Nasen und Ohrenheilkunde
Münster, Germany
Semmelweis Egyetem
Budapest, Hungary
Országos Onkológiai Intézet (National Institute of Oncology)
Budapest, Hungary
Debreceni Egyetem KLINIKAI KÖZPONT
Debrecen, Hungary
Semmelweis Egyetem
Szolnok, Hungary
Ospedali riuniti di Ancona - Clinica di Oncologia Medica
Ancona, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena-Policlinico di Modena
Modena, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara
Pisa, Italy
Prato Santo Stefano
Prato, Italy
Gruppo Humanitas Humanitas Research Hospital Rozzano Cancer Center
Rozzano, Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI) - Ospedale Borgo Trento
Verona, Italy
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE (IPO-Lisboa))
Lisbon, Portugal
Centro Hospitalar Universitario de Sao Joao
Lisbon, Portugal
Centro Hospitalar Universitario de Sao Joao
Porto, Portugal
Arensia Research Clinic Bucharest
Bucharest, Romania
Arensia Research Clinic Cluj-Napoca
Cluj-Napoca, Romania
Clinica de Oncologie Sf Nectarie
Craiova, Romania
Centrul de Oncologie-EUROCLINIC
Iași, Romania
OncoHelp - Ambulator OncoMed
Timișoara, Romania
Kosin University Gospel Hospital
Busan, South Korea
Chonbuk National University - Chonbuk National University Hospital - Jeonbuk Regional Cancer Center
Jeonju, South Korea
CHA University - CHA Bundang Medical Center (Bundang CHA General Hospital)
Seongnam, South Korea
Seoul National University Bundang Hospital - Comprehensive Cancer Center
Seongnam-si, South Korea
Severance Hospital - Yonsei Cancer Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Pusan National University Yangsan Hospital - Oncology/Hematology Clinic
Yangsan, South Korea
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Barcelona, Spain
Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals
Barcelona, Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, Spain
Institut Català D'oncologia Girona - Hospital Josep Trueta
Girona, Sevilla, Spain
Hospital Universitario Virgen del Rocio (HUVR)
Seville, Sevilla, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Hospital Universitario Miguel Servet (HUMS)
Zaragoza, Zaragoza, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital - Cancer Center
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital (CGMH)-Kaohsiung Branch
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital (VGHTC)
Taichung, Taiwan