Study Comparing CRB-701 to Standard Treatments for Previously Treated Throat Cancer
Sponsor: Corbus Pharmaceuticals Inc.
ClinicalTrials ID:NCT07768189
This clinical trial is testing a new targeted chemotherapy drug, CRB-701, to see if it can effectively treat oropharyngeal cancer (cancer of the throat and tonsils) in patients who have already tried other treatments. The study will also look at the safety of CRB-701 and its impact on patients' quality of life.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out if CRB-701, a new type of targeted chemotherapy, can help treat oropharyngeal cancer in patients who have already been treated with platinum-based chemotherapy or immunotherapy. The study will also assess the safety of CRB-701 and how it affects patients' quality of life. Researchers will compare CRB-701 to standard treatments to see which works better. Participants will receive either CRB-701 or standard treatment every three weeks and will have scans every six weeks to check the cancer's response. They will also fill out questionnaires about their health.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with oropharyngeal cancer (cancer of the throat, tonsils, base of tongue, soft palate, or back of the throat) that has spread or returned and cannot be treated with standard curative therapy.
- Have tried at least one previous treatment that included platinum chemotherapy and an anti-PD-(L)1 therapy, either separately or together, or as part of a treatment plan before or after surgery or radiation.
- Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one measurable tumor that has not been previously treated with radiation, unless it has clearly grown after radiation.
- Expected to live more than 12 weeks according to the doctor's assessment.
- Willing to sign an informed consent form.
Exclusion Criteria
- Have ongoing significant side effects from previous cancer treatments, except for hair loss.
- Have serious or ongoing eye problems affecting the cornea.
- Have existing moderate to severe nerve damage.
- Have other serious health conditions or lab results that could make the study drug unsafe or affect the study results.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clearview Cancer Institute | 38505 | Huntsville | Alabama |
| The University of Arizona Cancer Center | 85719 | Tucson | Arizona |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| University of California Los Angeles Westwood Cancer Center | 90095 | Los Angeles | California |
| Stanford Medicine - Cancer Center | 94304 | Palo Alto | California |
| Moores Cancer Center | 92037 | San Diego | California |
| UCSF Head and Neck Surgery Cancer Program | 94158 | San Francisco | California |
| UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado | 80920 | Colorado Springs | Colorado |
| Yale School of Medicine | 06510 | Newhaven | Connecticut |
| Medical Oncology Hematology Consultants | 19713 | Newark | Delaware |
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