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:

• Adults aged 18 or older who can understand the study, are not incarcerated, are willing to sign a consent form, and can attend scheduled visits and follow study requirements
• People who have a solid tumour cancer (confirmed by laboratory testing of tissue or cells) that has spread locally or to other parts of the body
• People whose cancer has continued to grow or spread after previous treatments, and for whom no other suitable treatment options are currently available
• People who are generally well enough to carry out light daily activities, with little or no limitation from their illness (this is measured on a standard scale rated 0 or 1)
• People who have at least one tumour that can be measured using standard imaging criteria
• People who have recovered sufficiently from side effects of previous cancer treatments (including drugs, radiation, or surgery) to safely take part in this study
• People whose liver is working adequately, based on specific blood test results within acceptable ranges
• People whose kidneys are working adequately, based on kidney function measurements meeting a minimum threshold
• People whose blood counts (white blood cells, platelets, and red blood cells) meet minimum levels on testing
• People living with HIV whose infection is well controlled on treatment, with adequate immune cell counts and very low virus levels (confirm with trial site)
• People whose blood clotting function falls within acceptable ranges (with adjustments for those already taking blood-thinning medication)
• People whose heart pumping function meets a minimum level, as measured by a heart scan
• People whose heart electrical activity (specifically a measurement called QTcF) falls within an acceptable range on testing
• Women who could become pregnant must have a negative pregnancy test and must agree to use two reliable methods of contraception from the screening period until four months after the last dose of the study drug
• Men who are sexually active with a partner who could become pregnant must agree to use barrier contraception, and their partner must also use an intrauterine device or hormonal contraception, from screening until four months after the last dose (this requirement may not apply to men who have had a vasectomy more than six months before signing the consent form)

Who may not be able to join:

• People with a history of another cancer, unless it was a skin cancer or an early-stage cancer that was fully treated, or another cancer from which the person has been free of disease for at least three years (people with prostate cancer under active monitoring may still be eligible)
• People with active cancer spread to the brain or the lining of the brain and spinal cord — though people with previously treated brain metastases may be eligible if scans show no growth for at least eight weeks and they require only a very low dose of steroid medication
• People who have received cancer treatment within 28 days (or within five times the drug's clearance time from the body, whichever is shorter) before the first dose of the study drug
• People who have had major surgery requiring general anaesthesia within 28 days before starting the study drug
• People who previously had to permanently stop an immunotherapy treatment due to serious immune-related side effects
• People who have previously received treatments targeting specific proteins called ILT2, ILT4, or HLA-G (confirm with trial site)
• People who have received a live or live-weakened vaccine within 28 days before starting the study drug
• People who are currently taking medications that suppress the immune system, with the exception of low-dose steroid creams applied to the skin or low oral steroid doses (people with adrenal gland insufficiency may be considered separately)
• People who have had a previous solid organ or bone marrow transplant (cornea transplants are an exception)
• People with a significant history of heart or blood vessel problems, including recent blood clots, heart attack, heart failure hospitalisation, bleeding disorders, stroke, uncontrolled high blood pressure, or irregular heartbeat (specific time windows apply — confirm with trial site)

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