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 aged 18 or older with head and neck cancer that cannot be surgically removed, or that has come back or spread, with at least one tumour that can be injected directly and is not planned for surgical removal — and who have previously received certain treatments including platinum-based chemotherapy, 5-Fluorouracil, taxane-based chemotherapy, cetuximab, or gemcitabine, as well as an immunotherapy drug that targets PD-1 or PD-L1, and whose cancer has clearly continued to grow after that immunotherapy (Cohort A)
• People with head and neck squamous cell cancer that has been confirmed by a tissue or cell sample, is at a stage where surgery is planned, and has at least one measurable tumour that can be surgically removed (Cohort C)
• People with a general health status rated as fully active or restricted only in physically strenuous activity, as assessed by a standard medical scoring system (ECOG 0–1)
• People whose tumour is larger than 1 cm in diameter and can be injected directly, as determined by the trial doctor or surgeon
• People with either a returned cancer at the original site or a new primary tumour
• People with blood and organ test results within the acceptable ranges required by the trial, including adequate blood cell counts, liver function, and haemoglobin levels
• People with a life expectancy of more than 12 weeks (approximately 3 months)
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures
• People who are able to understand the trial and are willing to sign a written consent form

Who may not be able to join:

• People whose tumours are located too close to vital organs or important blood vessels or nerves, making direct injection unsafe, as determined by the trial doctor or surgeon
• Women who are able to become pregnant and have not had a negative pregnancy test within the required timeframe before starting treatment; both women of childbearing potential and male participants (and their female partners) must agree to use two forms of effective contraception — one being a barrier method — or to abstain from sexual activity during the trial and for at least 6 months after the last dose
• People who are expected to receive other cancer treatments such as chemotherapy, immunotherapy, targeted therapy, or hormonal therapy (other than certain hormone-suppressing injections) before surgery, or whose side effects from previous treatments have not yet cleared
• People who have taken part in another clinical trial using an experimental treatment within the last 30 days
• People with ongoing illnesses that are not responding to medical treatment
• People who have used immune-suppressing medications in the 28 days before the first injection, except for low-dose inhaled, nasal, or oral steroids at or below a specified low daily limit
• People who are currently breastfeeding
• People who have had an organ transplant from another person that requires ongoing immune-suppressing medication
• People with an active or uncontrolled infection, including HIV, or known long-term hepatitis B or C infection
• People with any condition that, in the trial doctor's opinion, could interfere with assessing the treatment or the safety of the participant
• People with a known history of allergic reactions to any immune therapy drugs used in the trial

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