AzTrials
AzTrials

Oropharyngeal Carcinoma (OPC)Phase 3TEMPO-1NCT07768189

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

A Phase 3 study testing CRB-701, capcitabine and Cetuximab (EGFR inhibitor) in people with Oropharyngeal Carcinoma (OPC), run by Corbus Pharmaceuticals Inc. at 111 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharyngeal Carcinoma (OPC)
What is being tested?
CRB-701, capcitabine and Cetuximab (EGFR inhibitor)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
111 sitesin 14 countries
Study dates
29 Sep 2026to Mar 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

111 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Clinical Study Coordinator contact

1+(216) 444-8950

clinical@corbuspharma.com

111 sites in 14 countries

United States38 sites, 38 recruiting

  • Texas Oncology

    Austin, Texas, 78745

    Clinical Study Coordinator, 1+(512)-447-2202, clinical@corbuspharma.com

    James Uyeki, MD

    Not yet recruiting

  • University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Clinical Study Coordinator, 1+ (410)- 328-8667, clinical@corbuspharma.com

    Mehra

    Not yet recruiting

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

    Clinical Study Coordinator, +1 (443)-849-2540, clinical@corbuspharma.com

    Geoffrey Neuner, MD

    Not yet recruiting

  • Dana Faber Cancer Institute

    Boston, Massachusetts, 02215

    Clinical Study Coordinator, +1(877)-338-7425, clinical@corbuspharma.com

    Michael Dennis, MD

    Not yet recruiting

  • Gabrail Cancer Center and Research Center

    Canton, Ohio, 44718

    Clinical Study Coordinator, +1-(330)-492-3345, clinical@corbuspharma.com

    Nashat Gabrail, MD

    Recruiting

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425

    Clinical Study Coordinator, 1+ (843) 792-9300, clinical@corbuspharma.com

    John Kaczmar, MD

    Not yet recruiting

  • UVA Health - Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22908

    Clinical Study Coordinator, +1(434) 999-8757, clinical@corbuspharma.com

    Varinder Kaur, MD

    Not yet recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Clinical Study Coordinator, +1(855) 403-0529, clinical@corbuspharma.com

    Ari Rosenberg, MD

    Not yet recruiting

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

    Clinical Study Coordinator, 1+(216) 444-8950, clinical@corbuspharma.com

    Jessica Geiger, MD

    Not yet recruiting

  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado

    Colorado Springs, Colorado, 80920

    Clinical Study Coordinator, +1(719) 365-6568, clinical@corbuspharma.com

    Antonio Jimeno, MD

    Not yet recruiting

  • The Ohio State University Comprehensive Cancer Center The Arthur G.James

    Columbus, Ohio, 43210

    Clinical Study Coordinator, 1+ (614) 293-0463, clinical@corbuspharma.com

    Marcelo Bonomi, MD

    Not yet recruiting

  • Texas Oncology

    Dallas, Texas, 75246

    Clinical Study Coordinator, 1+(214)-370-1000, clinical@corbuspharma.com

    Eric Nadler, MD

    Not yet recruiting

  • Barbara Ann Karmanos Cancer Institute - Wayne State University

    Detroit, Michigan, 48201

    Clinical Study Coordinator, +1-(800)-537-6277, clinical@corbuspharma.com

    Ammar Sukari, MD

    Not yet recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Clinical Study Coordinator, +1 (877)-405-2009, clinical@corbuspharma.com

    Aditya Shreenivas, MD

    Not yet recruiting

  • Prisma Health Cancer Institute Multidisciplinary Center

    Greenville, South Carolina, 29605

    Clinical Study Coordinator, +1-(864)-455-7000, clinical@corbuspharma.com

    Richard O'Neal, MD

    Not yet recruiting

  • Clearview Cancer Institute

    Huntsville, Alabama, 38505

    Clinical Study Coordinator, 1+ (888)- 374-1015, clinical@corbuspharma.com

    Mehra

    Not yet recruiting

  • Iowa Health Care Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Clinical Study Coordinator, +1-319-356-4200, clinical@corbuspharma.com

    Douglas Laux, MD

    Not yet recruiting

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37919

    Clinical Study Coordinator, +1(865)- 862-3561, clinical@corbuspharma.com

    Richard Lee, MD

    Not yet recruiting

  • University of California Los Angeles Westwood Cancer Center

    Los Angeles, California, 90095

    Clinical Study Coordinator, +1-(310)-794-4955, clinical@corbuspharma.com

    Deborah Wong, MD

    Not yet recruiting

  • University of Louisville Health

    Louisville, Kentucky, 40202

    Clinical Study Coordinator, +1(502)552-4673, clinical@corbuspharma.com

    Rebecca Redman, MD

    Not yet recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

    Clinical Study Manager, +1 (615)-936-8422, clinical@corbuspharma.com

    Jennifer Choe, MD

    Not yet recruiting

  • NYU Langone Health Perlmutter Cancer Center

    New York, New York, 10016

    Clinical Study Coordinator, 1+ (212) 731-6465, clinical@corbuspharma.com

    Zujun Li, MD

    Not yet recruiting

  • Memorial Sloan Kettering

    New York, New York, 10021

    Clinical Study Coordinator, +1-(332)-378-0413, clinical@corbuspharma.com

    Alan Ho, MD

    Not yet recruiting

  • Medical Oncology Hematology Consultants

    Newark, Delaware, 19713

    Clinical Study Coordinator, 1+(302)-366-1200, clinical@corbuspharma.com

    Jamal Misleh, MD

    Not yet recruiting

  • Yale School of Medicine

    Newhaven, Connecticut, 06510

    Manager. Clinical Research Team for Head and Neck Cancer, +1-(474)-331-5081, sharon.huie@yale.edu

    Aarti Bhatia, MD

    Not yet recruiting

  • Nebraska Cancer Specialists - Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68130

    Clinical Study Coordinator, +1-(402)-717-4770, clinical@corbuspharma.com

    Yungpo Su, MD

    Recruiting

  • Florida Cancer Specialists and Research Institute

    Orlando, Florida, 32827

    Clinical Study Coordinator, +1 (407) 735-5695, clinical@corbuspharma.com

    Cesar Perez, MD

    Recruiting

  • Stanford Medicine - Cancer Center

    Palo Alto, California, 94304

    Clinical Study Coordinator, +1-(833)-444-7622, clinical@corbuspharma.com

    Hyunseok Kang, MD

    Not yet recruiting

  • Penn-Medicine - Abramson Cancer Center University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Clinical Study Coordinator, +1-(800)-789-7366, clinical@corbuspharma.com

    Lova Sun, MD

    Not yet recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Clinical Study Coordinator, +1-(844)-669-0274, clinical@corbuspharma.com

    Parth Desai, MD

    Not yet recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55059

    Clinical Study Coordinator, +1 (855) 776-0015, clinical@corbuspharma.com

    Katharine Price, MD

    Not yet recruiting

  • Moores Cancer Center

    San Diego, California, 92037

    Clinical Study Coordinator, +1-858-534-5555, clinical@corbuspharma.com

    Assuntina Sacco, MD

    Not yet recruiting

  • UCSF Head and Neck Surgery Cancer Program

    San Francisco, California, 94158

    Clinical Study Coordinator, +1-(415)-476-7119, clincal@corbuspharma.com

    Alain Algazi, MD

    Not yet recruiting

  • Fred Hutchinson Cancer Center Clinical - Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1024

    Clinical Study Coordinator, +1-(800).422.6237, clinical@corbuspharma.com

    Lauren Shih, MD

    Not yet recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63130

    Clinical Study Coordinator, +1 314-362-5000, clinical@corbuspharma.com

    Christine Auberle, MD

    Not yet recruiting

  • Moffitt Cancer Center Magnolia Campus

    Tampa, Florida, 33612

    Clinical Study Coordinator, +1-(844)-608-4821, clinical@corbuspharma.com

    Guilherme Rabinowits, MD

    Not yet recruiting

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Clinical Study Coordinator, +1-(520)-654-2873, UACC-Clinicaltrialsinfo@arizona.edu

    Ricklie Julian, MD

    Not yet recruiting

  • Northwest Cancer Center

    Vancouver, Washington, 98684

    Clinical Study Coordinator, +1-(360)-449-6521, clinical@corbuspharma.com

    Tristan Bice

    Not yet recruiting

Other trials in United States

United Kingdom9 sites, 9 recruiting

  • University Hospitals Birmingham -Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2GW

    +02078118111 Clinical Study Coordinator, +44(0)1213315000, clinical@corbuspharma.com

    Helen Clarke, MD

    Not yet recruiting

  • Cambridge University Hospitals

    Cambridge, CB2 0QQ

    Clinical Study Coordinator, +101223 805000, clinical@corbuspharma.com

    Will Ince, MD

    Not yet recruiting

  • Cancer Research UK Scotland Institute (Formerly the Cancer Research UK Beatson Institute)

    Glasgow, G61 1BD

    Clinical Study Coordinator, +201070477224 ext. 0151-556-5000, clinical@corbuspharma.com

    Derek Grose, MD

    Not yet recruiting

  • The Clatterbridge Cancer Centre

    Liverpool, L78YA

    Clinical Study Coordinator, +101223 805000 ext. 0151-556-5000, clinical@corbuspharma.com

    Christian Ottensmeier, MD

    Not yet recruiting

  • Barts Health NHS Trust

    London, London, E1 1RD

    Clinical Study Coordinator, +44 (020) 7882 5555, bartshealth.ecmc@nhs.net

    Pablo Nenclades, MD

    Not yet recruiting

  • The Royal Marsden

    London, SW3 6JJ

    Clinical Study Coordinator, +44 20 7352 8171, clinical@corbuspharma.com

    Kevin Harrington, MD

    Not yet recruiting

  • The Christie Hospital

    Manchester, M20 4BX

    +0(207)8118111 Clinical Study Coordinator, +0161 956 1167, clinical@corbuspharma.com

    Robert Metcalf, MD

    Not yet recruiting

  • Nottingham City Hospital

    Nottingham, NG5 1PB

    Clinical Study Coordinator, +441159691169, clinical@corbuspharma.com

    Judith Christian, MD

    Not yet recruiting

  • The Royal Marsden

    Sutton, Surrey, SM2 5PT

    +02078118111 Clinical Study Coordinator, clinical@corbuspharma.com

    Kevin Harrington, MD

    Not yet recruiting

Other trials in United Kingdom

South Korea8 sites, 8 recruiting

  • Kosin University Gospel Hospital

    Busan, 49267

    Clinical Study Coordinator, +886 7 312 1101, clinical@corbuspharma.com

    Seong-Hoon Shin, MD

    Not yet recruiting

  • Chonbuk National University - Chonbuk National University Hospital - Jeonbuk Regional Cancer Center

    Jeonju, 561-712

    Clinical Study Coordinator, +82-1577-7877, clinical@corbuspharma.com

    Eun-Kee Song, MD

    Not yet recruiting

  • CHA University - CHA Bundang Medical Center (Bundang CHA General Hospital)

    Seongnam, 13496

    Clinical Study Coordinator, +82-31-780-5000, clinical@corbuspharma.com

    Yun Beom Sang, MD

    Not yet recruiting

  • Seoul National University Bundang Hospital - Comprehensive Cancer Center

    Seongnam-si, 13620

    Clinical Study Coordinator, +82-1588-3369, clinical@corbuspharma.com

    Ji-Won Kim, MD

    Not yet recruiting

  • Severance Hospital - Yonsei Cancer Center

    Seoul, 03722

    Clinical Study Coordinator, +82 2-2228-1004, clinical@corbuspharma.com

    Min Hee Hong, MD

    Not yet recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Clinical Study Coordinator, +82 1577-9966, clinical@corbuspharma.com

    Eun Joo Kang, MD

    Not yet recruiting

  • Ajou University Hospital

    Suwon, 16499

    Clinical Study Coordinator, +82-1688-6114, clinical@corbuspharma.com

    Yong Won Choi, MD

    Not yet recruiting

  • Pusan National University Yangsan Hospital - Oncology/Hematology Clinic

    Yangsan, 50612

    Clinical Study Coordinator, +82 1577-7512, clinical@corbuspharma.com

    Junghoon Kim, MD

    Not yet recruiting

Other trials in South Korea

Spain8 sites, 8 recruiting

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, Barcelona, 08035

    Clinical Study Coordinator, +34 932 54 34 50, clinical@corbuspharma.com

    Irene Brana, MD

    Not yet recruiting

  • Hospital Clinic Barcelona

    Barcelona, Barcelona, 08036

    Clinical Study Coordinator, +34 932 27 54 00, clinical@corbuspharma.com

    Manuel Mazariegos, MD

    Not yet recruiting

  • Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals

    Barcelona, Barcelona, 08908

    Clinical Study Coordinator, +34 932 60 77 33, clinical@corbuspharma.com

    Maria Plana serrahima, MD

    Not yet recruiting

  • Institut Català D'oncologia Girona - Hospital Josep Trueta

    Girona, Sevilla, 17007

    Clinical Study Coordinator, +34 972 22 51 58, clinical@corbuspharma.com

    Jordi Rubio-Casadevall Rubio-Casadevall, MD

    Not yet recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Madrid, 28040

    Clinical Study Coordinator, +34 915 50 48 00, clinical@corbuspharma.com

    Pablo Flores-Paco, MD

    Not yet recruiting

  • Hospital Universitario Virgen del Rocio (HUVR)

    Seville, Sevilla, 41013

    Clinical Study Coordinator, +34 955 01 20 00, clinical@corbuspharma.com

    Maria jose Flor oncala, MD

    Not yet recruiting

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026

    Clinical Study Coordinator, +34 961 24 40 00, clinical@corbuspharma.com

    Javier Caballero Daroqui, MD

    Not yet recruiting

  • Hospital Universitario Miguel Servet (HUMS)

    Zaragoza, Zaragoza, 50009

    Clinical Study Coordinator, (+34) 976 189 498, clinical@corbuspharma.com

    Javier Martinez Trufero, PhD

    Not yet recruiting

Other trials in Spain

France7 sites, 7 recruiting

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André

    Bordeaux, 33075

    Clinical Study Coordinator, +33 5 56 79 56 79, clinical@corbuspharma.com

    Amaury Daste, MD

    Not yet recruiting

  • Centre Georges François Leclerc

    Dijon, 21079

    Clinical Study Coordinator, +33 3 80 73 75 00, clinical@corbuspharma.com

    Hélène Bellio, MD

    Not yet recruiting

  • UNICANCER-Centre Leon-Berard (CLB)

    Lyon, 69008

    Clinical Study Coordinator, 1: 33 (0) 4 78 78 28 28, clinical@corbuspharma.com

    Jerome Fayette, MD

    Not yet recruiting

  • Hopitaux de Marseille AP-HM - Hopital de La Timone

    Marseille, 13385

    Clinical Study Coordinator, +33 4 91 38 00 00, clinical@corbuspharma.com

    Sebastien Salas, MD

    Not yet recruiting

  • ICM - Institut du Cancer de Montpellier

    Montpellier, Sevilla, 34298

    Clinical Study Coordinator, +33 4 67 61 31 00, clinical@corbuspharma.com

    Quentin Thomas Thomas, MD

    Not yet recruiting

  • Institut Curie

    Paris, Sevilla, 75005

    Clinical Study Coordinator, +33 1 56 24 55 00, clinical@corbuspharma.com

    Edith Borcoman, MD

    Not yet recruiting

  • Institution: Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

    Saint-Herblain, Saint Herblain, 44805

    Clinical Study Coordinator, +33 2 40 67 99 00, clinical@corbuspharma.com

    Clemence Brac de la Perriere, MD

    Not yet recruiting

Other trials in France

Italy7 sites, 7 recruiting

  • Ospedali riuniti di Ancona - Clinica di Oncologia Medica

    Ancona, 60126

    Clinical Study Coordinator, +071 5964169, clinical@corbuspharma.com

    Rossana Berardi, MD

    Not yet recruiting

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milan, 20133

    Clinical Study Coordinator, +39 02 23901, clinical@corbuspharma.com

    Lisa Licitra, MD

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Modena-Policlinico di Modena

    Modena, 41125

    Clinical Study Coordinator, +39 059 422 2111, clinical@corbuspharma.com

    Martina Napolitano Napolitano, MD

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara

    Pisa, 56126

    Clinical Study Coordinator, +39 050 992111, clinical@corbuspharma.com

    Alessia Caldara, MD

    Not yet recruiting

  • Prato Santo Stefano

    Prato, 59100

    Clinical Study Coordinator, +39 0574 434766, clinical@corbuspharma.com

    Giacomo BALDI, MD

    Not yet recruiting

  • Gruppo Humanitas Humanitas Research Hospital Rozzano Cancer Center

    Rozzano, 20089

    Clinical Study Coordinator, +39 02 8224 6280., clinical@corbuspharma.com

    Paolo Bossi, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona (AOUI) - Ospedale Borgo Trento

    Verona, 37126

    Clinical Study Coordinator, +39 045 812 1111, clinical@corbuspharma.com

    Andrea Zivi, MD

    Not yet recruiting

Other trials in Italy

Taiwan6 sites, 6 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital - Cancer Center

    Kaohsiung City, 807

    Clinical Study Coordinator, +886-7-3121101, clinical@corbuspharma.com

    Hui-Ching Wang, MD

    Not yet recruiting

  • Chang Gung Memorial Hospital (CGMH)-Kaohsiung Branch

    Kaohsiung City, 833401

    Clinical Study Coordinator, +886 7 731 7123, clinical@corbuspharma.com

    Chih-Yen Chien, MD

    Not yet recruiting

  • China Medical University Hospital

    Taichung, 404327

    Clinical Study Coordinator, +886 4 22052121, clinical@corbuspharma.com

    Ching-Yun Hsieh, MD

    Not yet recruiting

  • Taichung Veterans General Hospital (VGHTC)

    Taichung, 407219

    Clinical Study Coordinator, +886 975 351 951, clinical@corbuspharma.com

    Yi-Chun Liu, MD

    Not yet recruiting

  • Chi Mei Hospital, Liouying

    Tainan, 73657

    Clinical Study Coordinator, +886-6226999, clinical@corbuspharma.com

    Chien-Liang Lin Lin, PhD

    Not yet recruiting

  • Taipei Veterans General Hospital (VGH)

    Taipei, 112

    Clinical Study Coordinator, +886 2 2871 2121, clinical@corbuspharma.com

    Muh-Hwa Yang, MD

    Not yet recruiting

Other trials in Taiwan

Belgium5 sites, 5 recruiting

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem, 2650

    Clinical Study Coordinator, +32 3 821 30 00, clinical@corbuspharma.com

    Marika Rasschaert, MD

    Not yet recruiting

  • UZ Gent

    Ghent, 9000

    Clinical Study Coordinator, +32 9 332 21 11, clinical@corbuspharma.com

    Michael Saerens, MD

    Not yet recruiting

  • UZ Leuven Gasthuisberg Campus

    Leuven, 3000

    Clinical Study Coordinator, +32 16 33 22 11, clinical@corbuspharma.com

    Paul Clement, MD

    Not yet recruiting

  • Vitaz - Sint-Niklaas Moerland

    Sint-Niklaas, 9100

    Clinical Study Coordinator, +32 3 760 60 60, clinical@corbuspharma.com

    Willem Lybaert, MD

    Not yet recruiting

  • Cliniques Universitaires Saint-Luc - Centre du Cancer

    Woluwe-Saint-Lambert, 1200

    Clinical Study Coordinator, +32 2 764 11 11, clinical@corbuspharma.com

    Jean-Pascal Machiels, MD

    Not yet recruiting

Other trials in Belgium

Canada5 sites, 5 recruiting

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

    Clinical Study Coordinator, +1 780-432-8771, clinical@corbuspharma.com

    Neil Chua, MD

    Not yet recruiting

  • Verspeeten Family Cancer Centre

    London, N6A 5W9

    Clinical Study Coordinator, +1 519-685-8600, clinical@corbuspharma.com

    Sara Kuruvilla, MD

    Not yet recruiting

  • Jewish General Hospital

    Montreal, H3T 1E2

    Clinical Study Coordinator, +1 514-340-8222, clinical@corbuspharma.com

    Khashayar Esfahani, MD

    Not yet recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6

    Clinical Study Coordinator, +613-737-7700, clinical@corbuspharma.com

    John Hilton, MD

    Not yet recruiting

  • Allan Blair Cancer Centre

    Regina, S4T 7T1

    Clinical Study Coordinator, +1 306-766-2213, clinical@corbuspharma.com

    Ayesha Bashir, MD

    Not yet recruiting

Other trials in Canada

Romania5 sites, 5 recruiting

  • Arensia Research Clinic Bucharest

    Bucharest, 11665

    Clinical Study Coordinator, +40 21 794 0302, clinical@corbuspharma.com

    Laurentia Gales, MD

    Not yet recruiting

  • Arensia Research Clinic Cluj-Napoca

    Cluj-Napoca, 400015

    Clinical Study Coordinator, +49 (211) 15 77 89 - 0, clinical@corbuspharma.com

    Tudor-Eliade Ciuleanu, MD

    Not yet recruiting

  • Clinica de Oncologie Sf Nectarie

    Craiova, 200801

    Clinical Study Coordinator, +40 731 604 432, clinical@corbuspharma.com

    Michael Schenker, MD

    Not yet recruiting

  • Centrul de Oncologie-EUROCLINIC

    Iași, 700106

    Clinical Study Coordinator, +40 232 263 888, clinical@corbuspharma.com

    Constantin Volovat, MD

    Not yet recruiting

  • OncoHelp - Ambulator OncoMed

    Timișoara, 300239

    Clinical Study Coordinator, 0753 595 959, clinical@corbuspharma.com

    Alexandra Kovacs, MD

    Not yet recruiting

Other trials in Romania

Hungary4 sites, 4 recruiting

  • Semmelweis Egyetem

    Budapest, 1085

    Clinical Study Coordinator, +36 1 459 1500, clinical@corbuspharma.com

    Laszlo Tamas Tamas, MD

    Not yet recruiting

  • Országos Onkológiai Intézet (National Institute of Oncology)

    Budapest, 1122

    Clinical Study Coordinator, +36 1 224 8600, clinical@corbuspharma.com

    Pinter Tamas, MD

    Not yet recruiting

  • Debreceni Egyetem KLINIKAI KÖZPONT

    Debrecen, 4032

    Clinical Study Coordinator, · +36 52 525 252, clinical@corbuspharma.com

    Péter Árkosy Árkosy, MD

    Not yet recruiting

  • Semmelweis Egyetem

    Szolnok, 5000

    Clinical Study Coordinator, +36 56 503 603, clinical@corbuspharma.com

    Zsuzsanna Orosz, MD

    Not yet recruiting

Other trials in Hungary

Austria3 sites, 3 recruiting

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010

    Clinical Study Coordinator, +43 732 76770, clinical@corbuspharma.com

    Andreas Strobl Strobl, MD

    Not yet recruiting

  • University Hospital Vienna

    Vienna, State of Vienna, 1090

    Clinical Study Coordinator, +43 (0)1 40400-39400, clinical@corbuspharma.com

    Thorsten Fuereder

    Not yet recruiting

  • University Hospital Vienna

    Vienna, 1090

    Clinical Study Coordinator, +43 1 404000, clinical@corbuspharma.com

    Thorsten Fuereder, MD

    Not yet recruiting

Other trials in Austria

Germany3 sites, 3 recruiting

  • Universitätsklinikum Köln - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde

    Cologne, 50937

    Clinical Study Coordinator, +49 221 4784754, clinical@corbuspharma.com

    Malte Suchan, MD

    Not yet recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

    Clinical Study Coordinator, +49 341 97109, clinical@corbuspharma.com

    Andreas Dietz, MD

    Not yet recruiting

  • Universitaetsklinikum Muenster (UKM) - Klinik fuer Hals, Nasen und Ohrenheilkunde

    Münster, 48149

    Clinical Study Coordinator, +49 251 8356811, clinical@corbuspharma.com

    +49 251 8356811

    Not yet recruiting

Other trials in Germany

Portugal3 sites, 3 recruiting

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE (IPO-Lisboa))

    Lisbon, 1099-023

    Clinical Study Coordinator, +351 21 722 9800, clinical@corbuspharma.com

    Joao Barata, PhD

    Not yet recruiting

  • Centro Hospitalar Universitario de Sao Joao

    Lisbon, 1350-352

    Clinical Study Coordinator, +351 21 392 6100, clinical@corbuspharma.com

    Leonor Ribeiro, MD

    Not yet recruiting

  • Centro Hospitalar Universitario de Sao Joao

    Porto, 4200-319

    Clinical Study Coordinator, +351 22 551 2100, clinical@corbuspharma.com

    Lucia Maria Nunes Aguas, MD

    Not yet recruiting

Other trials in Portugal

About this study

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

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.
Read more

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.
Being tested
CRB-701, capcitabine, Cetuximab (EGFR inhibitor), Docetaxel
Keywords
Antibody Drug Conjugate, Nectin-4, Oropharyngeal Squamous Cell Carcinoma, HPV-ve, HPV+ve, Head and Neck Squamous Cell Carcinoma
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRB-701Drug

    CRB-701 3.6mg/Kg administered intravenously every 21 days (Q3W)

  • capcitabineDrug

    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.

  • DocetaxelDrug

    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.

Study groups in NCT07768189
Study groupRoleWhat they receive
CRB-701Experimental3.6mg/Kg CRB-701 administered intravenously Q3W.
Receives: Drug: CRB-701
Investigator's Choice monotherapyActive comparatorInvestigator's choice of capecitabine, cetuximab or docetaxel
Receives: Drug: capcitabine; Drug: Cetuximab (EGFR inhibitor); Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (%)

    Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)

    Measured: Up to 24 months

  2. Overall Survival (months)

    Median time to death from any cause

    Measured: Approximately 3 years from randomization

Secondary outcomes (10)

  1. Progression Free Survival (Months)

    Median time to radiographic progression per RECIST 1.1 as assessed by BICR

    Measured: up to 24 months from randomization

  2. Duration of Response (Months)

    Duration of response to intervention as measured by RECIST 1.1 and assessed by BICR

    Measured: Up to approximately 2 years

  3. Change in baseline in EORTC QLQ-C30 functional and symptom scales

    Change from baseline in functional and symptom scales on the EORTC QLQ-C30 questionnaire. All individual functions and symptoms are measured on a scale ranging 1-4. In the functional scales a higher score represents better functioning and health. With the symptom scales a higher score represents a more severe symptom and poor health. A total score of 0-100 is derrived from the raw scores with a higher score indicating better health

    Measured: up to approximately 2 years

  4. Objective Response Rate (%)

    Proportion of participants that respond to treatment by RECIST 1.1 assessed by Investigator

    Measured: Up to approximate 2 years

  5. Time to Response (days)

    Median time to response as measured by RECIST 1.1 and asssessed by BICR

    Measured: up to approx 2 years

  6. Time to Response (days)

    Time to response as measured by RECIST v 1.1 as assessed by Investigator

    Measured: up to approximately 2 years

  7. Number of participants experiencing a treatment emergent adverse events

    Total number of participant experiencing adverse events per treatment group irrespective of relationship to study treatment.

    Measured: Up to approximately 2 years

  8. Number of participants experiencing a serious treatment emergent adverse event

    Number of participants who experienced a serious treatment emergent adverse events per treatment group irrespective of relationship to treatment.

    Measured: Up to approximately 2 years

  9. Number of participants that had a treatment modification due to an adverse event

    Number of participants that had a treatment modification due to an adverse event per treatment arm. Dose modifications include dose reductions and treatment delays.

    Measured: Up to approx. 2 years

  10. Number of participants who discontinued study treatment due to a treatment emergent adverse event

    Number of participants who discontinued study treatment due to a treatment adverse event per treatment group, irrespective of relationship to the study treatment.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start29 Sep 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind, multicenter, randomized controlled study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07768189
Sponsor's protocol ID
CRB-701-02
Other IDs
2026-527123-94-00
Acronym
TEMPO-1
Status last verified
Oct 2026
First submitted
12 Aug 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CRB-701, capcitabine and Cetuximab (EGFR inhibitor) in people with Oropharyngeal Carcinoma (OPC), run by Corbus Pharmaceuticals Inc. at 111 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in United States, United Kingdom, South Korea, Spain, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Study Coordinator (1+(216) 444-8950, clinical@corbuspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (%) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07768189.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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