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NCT07768189PHASE3Recruiting

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

Corbus Pharmaceuticals Inc.

Start Date

9/29/2026

Completion Date

3/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

CRB-701

DRUG

capcitabine

DRUG

Cetuximab (EGFR inhibitor)

DRUG

Docetaxel

Interested in This Trial?

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Conditions

Oropharyngeal Carcinoma (OPC)

Locations

Clearview Cancer Institute

Huntsville, Alabama 38505

United States

The University of Arizona Cancer Center

Tucson, Arizona 85719

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

University of California Los Angeles Westwood Cancer Center

Los Angeles, California 90095

United States

Stanford Medicine - Cancer Center

Palo Alto, California 94304

United States

Moores Cancer Center

San Diego, California 92037

United States

UCSF Head and Neck Surgery Cancer Program

San Francisco, California 94158

United States

UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado

Colorado Springs, Colorado 80920

United States

Yale School of Medicine

Newhaven, Connecticut 06510

United States

Medical Oncology Hematology Consultants

Newark, Delaware 19713

United States

Florida Cancer Specialists and Research Institute

Orlando, Florida 32827

United States

Moffitt Cancer Center Magnolia Campus

Tampa, Florida 33612

United States

University of Chicago

Chicago, Illinois 60637

United States

Iowa Health Care Holden Comprehensive Cancer Center

Iowa City, Iowa 52242

United States

University of Louisville Health

Louisville, Kentucky 40202

United States

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland 21201

United States

Greater Baltimore Medical Center

Baltimore, Maryland 21204

United States

Dana Faber Cancer Institute

Boston, Massachusetts 02215

United States

Barbara Ann Karmanos Cancer Institute - Wayne State University

Detroit, Michigan 48201

United States

Mayo Clinic in Rochester

Rochester, Minnesota 55059

United States

Washington University in St. Louis

St Louis, Missouri 63130

United States

Nebraska Cancer Specialists - Methodist Estabrook Cancer Center

Omaha, Nebraska 68130

United States

NYU Langone Health Perlmutter Cancer Center

New York, New York 10016

United States

Memorial Sloan Kettering

New York, New York 10021

United States

Gabrail Cancer Center and Research Center

Canton, Ohio 44718

United States

Cleveland Clinic Main Campus

Cleveland, Ohio 44195

United States

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

Columbus, Ohio 43210

United States

Penn-Medicine - Abramson Cancer Center University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

MUSC Hollings Cancer Center

Charleston, South Carolina 29425

United States

Prisma Health Cancer Institute Multidisciplinary Center

Greenville, South Carolina 29605

United States

Tennessee Cancer Specialists

Knoxville, Tennessee 37919

United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee 37232

United States

Texas Oncology

Austin, Texas 78745

United States

Texas Oncology

Dallas, Texas 75246

United States

UVA Health - Emily Couric Clinical Cancer Center

Charlottesville, Virginia 22908

United States

Fred Hutchinson Cancer Center Clinical - Seattle Cancer Care Alliance

Seattle, Washington 98109-1024

United States

Northwest Cancer Center

Vancouver, Washington 98684

United States

University Hospital Vienna

Vienna, State of Vienna 1090

Austria

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4010

Austria

University Hospital Vienna

Vienna, 1090

Austria

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, 2650

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven Gasthuisberg Campus

Leuven, 3000

Belgium

Vitaz - Sint-Niklaas Moerland

Sint-Niklaas, 9100

Belgium

Cliniques Universitaires Saint-Luc - Centre du Cancer

Woluwe-Saint-Lambert, 1200

Belgium

Cross Cancer Institute

Edmonton, T6G 1Z2

Canada

Verspeeten Family Cancer Centre

London, N6A 5W9

Canada

Jewish General Hospital

Montreal, H3T 1E2

Canada

The Ottawa Hospital Cancer Centre

Ottawa, K1H 8L6

Canada

Allan Blair Cancer Centre

Regina, S4T 7T1

Canada

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

Saint-Herblain, Saint Herblain 44805

France

ICM - Institut du Cancer de Montpellier

Montpellier, Sevilla 34298

France

Institut Curie

Paris, Sevilla 75005

France

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

Bordeaux, 33075

France

Centre Georges François Leclerc

Dijon, 21079

France

UNICANCER-Centre Leon-Berard (CLB)

Lyon, 69008

France

Hopitaux de Marseille AP-HM - Hopital de La Timone

Marseille, 13385

France

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

Cologne, 50937

Germany

Universitaetsklinikum Leipzig

Leipzig, 04103

Germany

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

Münster, 48149

Germany

Semmelweis Egyetem

Budapest, 1085

Hungary

Országos Onkológiai Intézet (National Institute of Oncology)

Budapest, 1122

Hungary

Debreceni Egyetem KLINIKAI KÖZPONT

Debrecen, 4032

Hungary

Semmelweis Egyetem

Szolnok, 5000

Hungary

Ospedali riuniti di Ancona - Clinica di Oncologia Medica

Ancona, 60126

Italy

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, 20133

Italy

Azienda Ospedaliero-Universitaria di Modena-Policlinico di Modena

Modena, 41125

Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara

Pisa, 56126

Italy

Prato Santo Stefano

Prato, 59100

Italy

Gruppo Humanitas Humanitas Research Hospital Rozzano Cancer Center

Rozzano, 20089

Italy

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

Verona, 37126

Italy

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

Lisbon, 1099-023

Portugal

Centro Hospitalar Universitario de Sao Joao

Lisbon, 1350-352

Portugal

Centro Hospitalar Universitario de Sao Joao

Porto, 4200-319

Portugal

Arensia Research Clinic Bucharest

Bucharest, 11665

Romania

Arensia Research Clinic Cluj-Napoca

Cluj-Napoca, 400015

Romania

Clinica de Oncologie Sf Nectarie

Craiova, 200801

Romania

Centrul de Oncologie-EUROCLINIC

Iași, 700106

Romania

OncoHelp - Ambulator OncoMed

Timișoara, 300239

Romania

Kosin University Gospel Hospital

Busan, 49267

South Korea

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

Jeonju, 561-712

South Korea

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

Seongnam, 13496

South Korea

Seoul National University Bundang Hospital - Comprehensive Cancer Center

Seongnam-si, 13620

South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, 03722

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Ajou University Hospital

Suwon, 16499

South Korea

Pusan National University Yangsan Hospital - Oncology/Hematology Clinic

Yangsan, 50612

South Korea

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, Barcelona 08035

Spain

Hospital Clinic Barcelona

Barcelona, Barcelona 08036

Spain

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

Barcelona, Barcelona 08908

Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Madrid 28040

Spain

Institut Català D'oncologia Girona - Hospital Josep Trueta

Girona, Sevilla 17007

Spain

Hospital Universitario Virgen del Rocio (HUVR)

Seville, Sevilla 41013

Spain

Hospital Universitario La Fe

Valencia, Valencia 46026

Spain

Hospital Universitario Miguel Servet (HUMS)

Zaragoza, Zaragoza 50009

Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital - Cancer Center

Kaohsiung City, 807

Taiwan

Chang Gung Memorial Hospital (CGMH)-Kaohsiung Branch

Kaohsiung City, 833401

Taiwan

China Medical University Hospital

Taichung, 404327

Taiwan

Taichung Veterans General Hospital (VGHTC)

Taichung, 407219

Taiwan

Chi Mei Hospital, Liouying

Tainan, 73657

Taiwan

Taipei Veterans General Hospital (VGH)

Taipei, 112

Taiwan

Barts Health NHS Trust

London, London E1 1RD

United Kingdom

The Royal Marsden

Sutton, Surrey SM2 5PT

United Kingdom

University Hospitals Birmingham -Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW

United Kingdom

Cambridge University Hospitals

Cambridge, CB2 0QQ

United Kingdom

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

Glasgow, G61 1BD

United Kingdom

The Clatterbridge Cancer Centre

Liverpool, L78YA

United Kingdom

The Royal Marsden

London, SW3 6JJ

United Kingdom

The Christie Hospital

Manchester, M20 4BX

United Kingdom

Nottingham City Hospital

Nottingham, NG5 1PB

United Kingdom