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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
2026-09-20
Completion Date
2029-03
Last Updated
2026-08-20
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 (27)
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
Aurora, Colorado, United States
Yale School of Medicine
Newhaven, Connecticut, 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
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
Nebraska Cancer Specialists - Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Memorial Sloan Kettering
New York, New York, United States
Grabrail Cancer Center and Research Center
Canton, Ohio, United States
Penn-Medicine - Abramson Cancer Center University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Prisma Health Cancer Institute Multidisciplinary Center
Greenville, South Carolina, 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
Barts Health NHS Trust
London, London, United Kingdom