Can a smart chemo drug outsmart advanced throat cancer?
NCT ID NCT07768189
First seen Aug 17, 2026 · Last updated Sep 01, 2026 · Updated 7 times
Summary
This trial is testing whether CRB-701, a targeted chemotherapy that delivers a potent drug directly to cancer cells, can shrink tumors and extend life in people with recurrent or metastatic oropharyngeal (throat or tonsil) cancer. Participants will have already tried platinum-based chemotherapy and immunotherapy. The study compares CRB-701 to standard options like capecitabine, cetuximab, or docetaxel, measuring response rates, survival, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CRB-701, a targeted chemotherapy (antibody-drug conjugate) given by IV every 3 weeks
- What this could lead to
- If successful, CRB-701 could offer a new, more effective treatment option for people with advanced throat cancer who have run out of standard options.
- What could go wrong
- This is an early-stage test in a specific group of patients, and the drug may not prove better than existing treatments or may cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Oropharyngeal carcinoma (OPC) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
29 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Barbara Ann Karmanos Cancer Institute - Wayne State University
Detroit, Michigan, 48201, United States
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Barts Health NHS Trust
London, London, E1 1RD, United Kingdom
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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Dana Faber Cancer Institute
Boston, Massachusetts, 02215, United States
Contact Email: •••••@•••••
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Florida Cancer Specialists and Research Institute
Orlando, Florida, 32827, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Fred Hutchinson Cancer Center Clinical - Seattle Cancer Care Alliance
Seattle, Washington, 98109-1024, United States
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Grabrail Cancer Center and Research Center
Canton, Ohio, 44718, United States
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Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
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Iowa Health Care Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Contact Email: •••••@•••••
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Mayo Clinic in Rochester
Rochester, Minnesota, 55059, United States
Contact Email: •••••@•••••
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Memorial Sloan Kettering
New York, New York, 10021, United States
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Moffitt Cancer Center Magnolia Campus
Tampa, Florida, 33612, United States
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Moores Cancer Center
San Diego, California, 92037, United States
Contact Email: •••••@•••••
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Nebraska Cancer Specialists - Methodist Estabrook Cancer Center
Omaha, Nebraska, 68130, United States
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Northwest Cancer Center
Vancouver, Washington, 98684, United States
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Penn-Medicine - Abramson Cancer Center University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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Prisma Health Cancer Institute Multidisciplinary Center
Greenville, South Carolina, 29605, United States
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Stanford Medicine - Cancer Center
Palo Alto, California, 94304, United States
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The University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
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UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado
Aurora, Colorado, 80045, United States
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UCSF Head and Neck Surgery Cancer Program
San Francisco, California, 94158, United States
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UVA Health - Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22908, United States
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University Hospital Vienna
Vienna, State of Vienna, 1090, Austria
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University of California Los Angeles Westwood Cancer Center
Los Angeles, California, 90095, United States
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University of Chicago
Chicago, Illinois, 60637, United States
Contact Email: •••••@•••••
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Washington University in St. Louis
St Louis, Missouri, 63130, United States
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Yale School of Medicine
Newhaven, Connecticut, 06510, United States
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