NCT07768189RecruitingPhase 3
A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 12 Aug 2026
- Start date
- 29 Sept 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Diseases
- Head and neck cancer
- NCT number
- NCT07768189
- EU CT number
- 2026-527123-94-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 260
- From 29 Sept 2026 to the primary completion date, Dec 2027
- 110 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persistent CTCAE Grade \>1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia.
Other illness
- Significant active or chronic corneal disorders
Lab values
- 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.
Other
- Pre-existing Grade ≥2 peripheral neuropathy
- Pregnant or breastfeeding females
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (110)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz Barmherzige Schwestern Coordinator of this site? Confirm its status | Linz | Austria | Not yet recruiting |
| University Hospital Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Universitair Ziekenhuis Antwerpen (Uza) Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
| UZ Leuven - Gasthuisberg Campus Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Vitaz - Sint-Niklaas Moerland Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Not yet recruiting |
| Cliniques Universitaires Saint-Luc - Centre du Cancer Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Not yet recruiting |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| Verspeeten Family Cancer Centre Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Not yet recruiting |
| Allan Blair Cancer Centre Coordinator of this site? Confirm its status | Regina | Canada | Not yet recruiting |
| Universitätsklinikum Köln - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| Universitaetsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Universitaetsklinikum Muenster (UKM) - Klinik fuer Hals, Nasen und Ohrenheilkunde Coordinator of this site? Confirm its status | Münster | Germany | Not yet recruiting |
| Vall d'Hebron Institute of Oncology (VHIO) Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals, Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Institut Catala D'Oncologia Girona - Hospital Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Virgen Del Rocio (Huvr) Coordinator of this site? Confirm its status | Seville | Spain | Not yet recruiting |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Universitario Miguel Servet (HUMS) Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| UNICANCER - Centre Leon Berard (CLB) Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Hopitaux de Marseille AP-HM - Hopital de La Timone Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| ICM - Institut du Cancer de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Not yet recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Institution: Institut de Cancerologie de Ouest (ICO) - Saint-Herblain Coordinator of this site? Confirm its status | Saint-Herblain | France | Not yet recruiting |
| University Hospitals Birmingham -Queen Elizabeth Hospital Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Not yet recruiting |
| Cambridge University Hospitals Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Not yet recruiting |
| Cancer Research UK Scotland Institute (Formerly the Cancer Research UK Beatson Institute) Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Not yet recruiting |
| The Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Not yet recruiting |
| The Royal Marsden Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| The Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Not yet recruiting |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Not yet recruiting |
| The Royal Marsden Coordinator of this site? Confirm its status | Sutton | United Kingdom | Not yet recruiting |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Not yet recruiting |
| Orszagos Onkologiai Intezet (National Institute of Oncology) Coordinator of this site? Confirm its status | Budapest | Hungary | Not yet recruiting |
| Debreceni Egyetem Klinikai Kozpont Coordinator of this site? Confirm its status | Debrecen | Hungary | Not yet recruiting |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Szolnok | Hungary | Not yet recruiting |
| Ospedali riuniti di Ancona - Clinica di Oncologia Medica Coordinator of this site? Confirm its status | Ancona | Italy | Not yet recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria di Modena-Policlinico di Modena Coordinator of this site? Confirm its status | Modena | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| Prato Santo Stefano Coordinator of this site? Confirm its status | Prato | Italy | Not yet recruiting |
| Gruppo Humanitas Humanitas Research Hospital Rozzano Cancer Center Coordinator of this site? Confirm its status | Rozzano | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Integrata Verona (AOUI) - Ospedale Borgo Trento Coordinator of this site? Confirm its status | Verona | Italy | Not yet recruiting |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Not yet recruiting |
| Chonbuk National University - Chonbuk National University Hospital - Jeonbuk Regional Cancer Center Coordinator of this site? Confirm its status | Jeonju | South Korea | Not yet recruiting |
| CHA University - CHA Bundang Medical Center (Bundang CHA General Hospital) Coordinator of this site? Confirm its status | Seongnam | South Korea | Not yet recruiting |
| Seoul National University Bundang Hospital - Comprehensive Cancer Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Not yet recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Severance Hospital Yonsei Cancer Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Not yet recruiting |
| Pusan National University Yangsan Hospital - Oncology/Hematology Clinic Coordinator of this site? Confirm its status | Yangsan | South Korea | Not yet recruiting |
| Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE (IPO-Lisboa)) Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Centro Hospitalar Universitario de Sao Joao Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Centro Hospitalar Universitário de São João Coordinator of this site? Confirm its status | Porto | Portugal | Not yet recruiting |
| Arensia Research Clinic Bucharest Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Arensia Research Clinic Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Not yet recruiting |
| Clinica de Oncologie Sf Nectarie Coordinator of this site? Confirm its status | Craiova | Romania | Not yet recruiting |
| Centrul de Oncologie Euroclinic Coordinator of this site? Confirm its status | Iași | Romania | Not yet recruiting |
| OncoHelp - Ambulator OncoMed Coordinator of this site? Confirm its status | Timișoara | Romania | Not yet recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital - Cancer Center Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Not yet recruiting |
| Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Not yet recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Not yet recruiting |
| Taichung Veterans General Hospital (VGHTC) Coordinator of this site? Confirm its status | Taichung | Taiwan | Not yet recruiting |
| Chi Mei Hospital, Liouying Coordinator of this site? Confirm its status | Tainan | Taiwan | Not yet recruiting |
| Taipei Veterans General Hospital (VGH) Coordinator of this site? Confirm its status | Taipei | Taiwan | Not yet recruiting |
| Texas Oncology Coordinator of this site? Confirm its status | Austin | United States | Not yet recruiting |
| Greater Baltimore Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Not yet recruiting |
| University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Not yet recruiting |
| Dana Faber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Gabrail Cancer Center and Research Center Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| MUSC Hollings Cancer Center Coordinator of this site? Confirm its status | Charleston | United States | Not yet recruiting |
| UVA Health - Emily Couric Clinical Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Not yet recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Cleveland Clinic - Main Campus Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Coordinator of this site? Confirm its status | Colorado Springs | United States | Not yet recruiting |
| The Ohio State University Comprehensive Cancer Center The Arthur G.James Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| Texas Oncology Coordinator of this site? Confirm its status | Dallas | United States | Not yet recruiting |
| Barbara Ann Karmanos Cancer Institute - Wayne State University Coordinator of this site? Confirm its status | Detroit | United States | Not yet recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Not yet recruiting |
| Prisma Health Cancer Institute Multidisciplinary Center Coordinator of this site? Confirm its status | Greenville | United States | Not yet recruiting |
| Clearview Cancer Institute Coordinator of this site? Confirm its status | Huntsville | United States | Not yet recruiting |
| Iowa Health Care Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Not yet recruiting |
| Tennessee Cancer Specialists Coordinator of this site? Confirm its status | Knoxville | United States | Not yet recruiting |
| University of California Los Angeles Westwood Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| University of Louisville Health Coordinator of this site? Confirm its status | Louisville | United States | Not yet recruiting |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| Medical Oncology Hematology Consultants Coordinator of this site? Confirm its status | Newark | United States | Not yet recruiting |
| Yale School of Medicine Coordinator of this site? Confirm its status | Newhaven | United States | Not yet recruiting |
| NYU Langone Health Perlmutter Cancer Center Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Memorial Sloan Kettering Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Nebraska Cancer Specialists - Methodist Estabrook Cancer Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Florida Cancer Specialists and Research Institute Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Stanford Medicine Cancer Center Coordinator of this site? Confirm its status | Palo Alto | United States | Not yet recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Penn-Medicine - Abramson Cancer Center University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Not yet recruiting |
| Moores Cancer Center Coordinator of this site? Confirm its status | San Diego | United States | Not yet recruiting |
| UCSF Head and Neck Surgery Cancer Program Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| Fred Hutchinson Cancer Center Clinical - Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Not yet recruiting |
| Moffitt Cancer Center - Magnolia Campus Coordinator of this site? Confirm its status | Tampa | United States | Not yet recruiting |
| The University of Arizona Cancer Center Coordinator of this site? Confirm its status | Tucson | United States | Not yet recruiting |
| Northwest Cancer Center Coordinator of this site? Confirm its status | Vancouver | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.