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Can a smart chemo drug outsmart advanced throat cancer?

NCT ID NCT07768189

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    29 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Barbara Ann Karmanos Cancer Institute - Wayne State University

    Detroit, Michigan, 48201, United States

  • Barts Health NHS Trust

    London, London, E1 1RD, United Kingdom

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Dana Faber Cancer Institute

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • Florida Cancer Specialists and Research Institute

    Orlando, Florida, 32827, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center Clinical - Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1024, United States

  • Grabrail Cancer Center and Research Center

    Canton, Ohio, 44718, United States

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204, United States

  • Iowa Health Care Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55059, United States

    Contact Email: •••••@•••••

  • Memorial Sloan Kettering

    New York, New York, 10021, United States

  • Moffitt Cancer Center Magnolia Campus

    Tampa, Florida, 33612, United States

  • Moores Cancer Center

    San Diego, California, 92037, United States

    Contact Email: •••••@•••••

  • Nebraska Cancer Specialists - Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68130, United States

  • Northwest Cancer Center

    Vancouver, Washington, 98684, United States

  • Penn-Medicine - Abramson Cancer Center University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Prisma Health Cancer Institute Multidisciplinary Center

    Greenville, South Carolina, 29605, United States

  • Stanford Medicine - Cancer Center

    Palo Alto, California, 94304, United States

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719, United States

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

    Aurora, Colorado, 80045, United States

  • UCSF Head and Neck Surgery Cancer Program

    San Francisco, California, 94158, United States

  • UVA Health - Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22908, United States

  • University Hospital Vienna

    Vienna, State of Vienna, 1090, Austria

  • University of California Los Angeles Westwood Cancer Center

    Los Angeles, California, 90095, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63130, United States

  • Yale School of Medicine

    Newhaven, Connecticut, 06510, United States

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Other studies related to the condition(s) this trial covers.