Phase 1 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 who have head and neck squamous cell carcinoma (a type of cancer affecting the mouth, throat, or related areas) that has come back or spread to other parts of the body.
• People aged 18 or older.
• People whose general physical condition is reasonably functional — rated on a scale used by doctors to measure how much cancer affects daily activities (confirm with trial site for exact rating details).
• People whose blood cell counts and organ function meet specific laboratory thresholds — including white blood cell levels, haemoglobin, platelets, kidney function, and liver enzyme levels (the trial site will check these through blood tests).
• Women who could become pregnant must have a negative pregnancy test taken less than 5 days before starting the trial.
• Women who could become pregnant and men must agree to use appropriate contraception during treatment and for 180 days after the last dose.
• People with hepatitis B who test positive for a certain antibody, as long as the hepatitis B virus is undetectable in the blood by a specific test.
• People with hepatitis C antibodies, as long as the hepatitis C virus is undetectable in the blood by a specific test.
• People living with HIV, as long as they are consistently taking their HIV medication, have had a stable immune cell count above 300 for at least 6 months, and have an undetectable viral load.
• People who are able to understand the trial and agree to take part, and who are expected to live for more than 12 weeks.

Who may not be able to join:

• People currently taking part in another interventional clinical trial (participation in a non-interventional observational study, or being in a follow-up phase of a previous trial, may be acceptable — confirm with trial site).
• People who have received an experimental cancer treatment within the past 28 days (or within 5 half-lives of the drug, whichever is shorter).
• People currently receiving any other chemotherapy, experimental agent, biological therapy, or hormonal cancer treatment (hormonal therapy for non-cancer reasons, such as hormone replacement therapy, is generally acceptable).
• People who have had radiation treatment covering more than 30% of the bone marrow, or large-field radiation, within the 4 weeks before starting the trial.
• People who have had radiation to the chest area greater than a certain dose within the 6 months before starting the trial, or who have not recovered from radiation-related side effects.
• People who have had a major surgical procedure within 28 days before starting the trial (minor local surgery for symptom relief may be acceptable — confirm with trial site).
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor.
• People with serious uncontrolled medical conditions, such as active infections, uncontrolled heart problems, uncontrolled high blood pressure, unstable lung disease, serious ongoing digestive conditions involving diarrhoea, or significant mental health or social circumstances that could affect safe participation.
• People who have had another type of cancer in the past, unless it was treated with the intent to cure, has shown no signs of returning for at least 1.5 years, and carries a low risk of coming back — or unless it was a type of non-melanoma skin cancer or pre-invasive cancer that was fully treated with no evidence of disease remaining.
• People with a history of cancer spreading to the membranes surrounding the brain or spinal cord.
• People who have untreated brain metastases (cancer that has spread to the brain). People whose brain metastases have been treated may be considered, provided scans taken at least four weeks apart show no new growth, any related neurological symptoms have stabilised or resolved, and steroid use (if any) is at a low, stable dose for at least 14 days before starting (confirm with trial site).
• People with a history of a primary immune deficiency condition.
• People with an active tuberculosis infection.
• People with an active autoimmune disease that requires immune-suppressing medication above a low maintenance level (certain limited uses of steroids — such as inhalers, eye drops, skin creams, or joint injections — may still be acceptable — confirm with trial site).
• People who have received a live vaccine within 28 days before starting the trial.
• People with a known allergy or sensitivity to the study drug or similar substances.
• People who still have significant unresolved side effects (grade 2 or higher on a standard medical scale) from a previous cancer treatment, with some exceptions such as hair loss or skin pigment changes.
• People who experienced serious immune-related side effects during a previous immunotherapy treatment that led to that treatment being permanently stopped, or that required heavy or prolonged immune-suppressing treatment to manage.
• People who have taken oral antibiotics within 7 days before starting the trial.

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