Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years, of any gender
• People whose cancer has been confirmed by laboratory testing (biopsy or cell sample) as a specific type of head and neck cancer called squamous cell carcinoma, affecting the throat, mouth, voice box, or lower throat area, that cannot be cured with local treatment
• People whose cancer has come back or spread, and who have not yet received systemic (whole-body) treatment for the cancer in this recurrent or advanced stage — prior treatment for earlier-stage disease is allowed if it finished more than 6 months before joining the trial
• People who are in reasonably good physical condition, rated 0 or 1 on a standard activity scale (confirm with trial site)
• People expected to live at least 12 weeks
• People who have at least one tumour that can be measured on scans, following standard measurement rules
• People who have tumour tissue available for testing — either stored tissue from within the last 2 years or a fresh sample
• People whose tumour tests show certain protein markers: a score called PD-L1 CPS of 1 or higher, and a positive result for a protein called Trop2
• People with throat cancer (oropharyngeal cancer) who have been tested for a marker called P16
• People whose blood, liver, kidney, and heart function all meet specific normal or near-normal levels within 2 weeks before starting treatment (confirm exact thresholds with trial site)
• Women of childbearing potential who have a negative pregnancy test within 7 days before the first dose
• People who agree to use highly effective contraception throughout the trial and for 12 months after treatment ends
• People who voluntarily agree to take part, sign a consent form, and are willing to attend follow-up visits
• People whose treating doctor believes may benefit from this treatment

Who may not be able to join:

• People whose cancer got worse within 6 months of finishing systemic treatment for locally advanced head and neck cancer
• People with a history of nasopharyngeal cancer (a specific cancer at the back of the nose)
• People who have cancer that has spread to the brain or the lining around the brain
• People who currently have significant hearing loss (grade 2 or above) or nerve damage (grade 2 or above) while receiving cancer treatment
• People who have taken part in another clinical drug or therapy trial within 4 weeks before the first dose
• People who have received certain blood-stimulating medications (such as G-CSF or erythropoietin) within 1 week before the first dose
• People who test positive for HIV or syphilis
• People with active hepatitis B or hepatitis C, based on specific blood test results (confirm details with trial site)
• People with active lung conditions such as interstitial lung disease, pneumonia, chronic obstructive pulmonary disease, or active tuberculosis — some forms of childhood asthma that have fully resolved may be allowed (confirm with trial site)
• People with an active autoimmune disease or a history of autoimmune disease — some mild conditions such as vitiligo may be allowed (confirm with trial site)
• People currently using immunosuppressant medications or high-dose steroid medications within 2 weeks before joining
• People with uncontrolled ongoing health problems, including serious infection, poorly controlled diabetes, advanced heart failure, or certain serious heart or blood vessel events within the past 6 months (such as heart attack, stroke, blood clots, or major heart procedures)
• People with large amounts of fluid around the lungs or in the abdomen that require treatment
• People who have taken certain medications that affect how the liver processes drugs (CYP3A4 inhibitors) within 1 week before screening (confirm with trial site)
• People who have previously had a stem cell or organ transplant
• People with a history of substance abuse that cannot be managed, or a history of significant mental health disorders
• People who have had another type of cancer within the past 5 years — exceptions include certain fully treated skin cancers, early prostate cancer, and cervical carcinoma in situ
• People whose doctor judges them unlikely to follow the trial requirements, or who have other conditions making participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.