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RECRUITING Phase 3 ClinicalTrials.gov

A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma

Sponsor: Corbus Pharmaceuticals Inc. • ClinicalTrials.gov ID: NCT07768189

Registry updated: 2026-10-08
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Description

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.

Interventions

  • CRB-701 (Drug)
    CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)
  • capcitabine (Drug)
    1250 mg/m2 twice daily on days 1-14 of each 21-day cycle
  • Cetuximab (EGFR inhibitor) (Drug)
    400mg/m2 loading dose followed by 250mg/m2 weekly as an IV infusion or 500mg/m2 every 2 weeks.
  • Docetaxel (Drug)
    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.

Eligibility criteria

Inclusion Criteria: * Histological and/or cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent. * Either second or third-line OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and/or anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy. * ECOG PS of 0-1 * Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation. * Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment. Signed informed consent Exclusion Criteria: * Persistent CTCAE Grade \>1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia. * Significant active or chronic corneal disorders * Pre-existing Grade ≥2 peripheral neuropathy * Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results. * Pregnant or breastfeeding females

Conditions

Oropharyngeal Carcinoma (OPC)

Locations

  • 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
  • Chi Mei Hospital, Liouying — Tainan, Taiwan
  • Taipei Veterans General Hospital (VGH) — Taipei, Taiwan
  • Barts Health NHS Trust — London, London, United Kingdom
  • The Royal Marsden — Sutton, Surrey, United Kingdom
  • University Hospitals Birmingham -Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom
  • Cambridge University Hospitals — Cambridge, United Kingdom
  • Cancer Research UK Scotland Institute (Formerly the Cancer Research UK Beatson Institute) — Glasgow, United Kingdom
  • The Clatterbridge Cancer Centre — Liverpool, United Kingdom
  • The Royal Marsden — London, United Kingdom
  • The Christie Hospital — Manchester, United Kingdom
  • Nottingham City Hospital — Nottingham, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record