Phase 2 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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
• People with a biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (a type of cancer affecting the head and neck region), either new or returning — or where the investigator has strong clinical suspicion of this diagnosis
• For Part 1 of the trial: people with Stage 1 to 4 head and neck squamous cell carcinoma
• For Part 2 of the trial: people with squamous cell carcinoma that has spread to at least one lymph node in the neck, where the original location of the cancer has not been confirmed by biopsy
• People with acceptable blood counts, kidney function, and liver function, as assessed by the investigator using standard surgical guidelines (certain abnormal lab results may still be acceptable if the investigator and medical monitor determine they are not clinically significant)
• Women who could potentially become pregnant must have a documented negative blood pregnancy test before joining
• Men and women who could potentially become pregnant must agree to use an approved form of contraception (such as surgical sterilisation, an IUD, oral contraceptives, contraceptive patch, long-acting injectable contraception, partner's vasectomy, a double-barrier method, or abstinence) during the trial and for 6 months after it ends
• People who agree to avoid all alcohol starting 72 hours before receiving the study drug and until the Day 10 study visit
• People who are likely to be available for follow-up appointments as required

Who may not be able to join:

• People whose tumour is located in an area where the surgeon determines that imaging during surgery would not be possible
• People with a life expectancy of less than 12 weeks
• People with a low physical functioning score (below 70% on the Karnofsky Performance Scale, which measures a person's ability to carry out daily activities) (confirm with trial site)
• People with significant liver disease, including active hepatitis, cirrhosis, or impaired liver function above a certain severity level (Child-Pugh score above 5) (confirm with trial site)
• People with lab results, symptoms, or medical conditions that the principal investigator determines would prevent surgery
• People with medical or mental health conditions that affect their ability to give informed consent
• Women who are pregnant or breastfeeding
• People who are currently taking, or plan to take during the study, medications that carry a high risk of causing liver damage, as determined by the principal investigator
• People who have consumed alcohol within 72 hours before receiving the study drug
• People who have taken another investigational (experimental) drug within 30 days — or within 5 half-lives of that drug, whichever is shorter — before receiving the study drug
• People who would be unable to attend scheduled assessments or whose circumstances might affect the reliability of study results
• People whom the principal investigator considers should not participate for any reason

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