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:

• Adults aged 18 to 75 years old
• People with head and neck squamous cell carcinoma (a type of cancer) that has come back or spread to other parts of the body
• People with a life expectancy of at least 3 months
• People who are generally well enough to carry out light activity (with minimal limitations on daily life), as assessed by a standard health scoring system
• People who have at least one tumour that can be measured on scans, according to standard criteria
• People willing to provide a tumour tissue sample, either a new one or one taken within the past 2 years
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better
• People with good heart function, with the heart pumping at least 50% of its capacity
• People with acceptable blood, kidney, liver, and clotting function levels as defined by the trial (confirm with trial site)
• People with low levels of protein in their urine, within the limits set by the trial
• People who are able and willing to sign a consent form and follow the trial requirements
• People who are able to use highly effective contraception if there is any chance of pregnancy — this applies from 7 days before the first dose until 24 weeks after the last dose
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose

Who may not be able to join:

• People whose squamous cell carcinoma started in the nasopharynx, salivary glands, sinuses, skin, or from an unknown primary location
• People whose cancer can be treated with local treatments, or who have already received systemic (whole-body) therapy for recurrent or metastatic disease (confirm with trial site)
• People with active cancer that has spread to the brain or spinal cord
• People who have taken part in another clinical trial within the past 4 weeks
• People who have had radiotherapy within the 4 weeks before joining
• People who have used traditional Chinese herbal medicines with anti-cancer properties within the past 2 weeks
• People who have had major surgery within the past 4 weeks
• People who have needed steroid medications or immune-suppressing drugs within the past 2 weeks
• People with significant lung disease, including a history of scarring or inflammation of the lung tissue (interstitial lung disease)
• People with an active serious infection currently being treated with intravenous antibiotics or antifungals
• People who previously received immunotherapy and experienced serious immune-related side effects (grade 3 or higher, or grade 2 or higher for heart-related immune reactions)
• People who have received a live vaccine within the past 4 weeks
• People who have taken immune-modifying drugs within the past 14 days
• People with an active autoimmune disease, or a significant history of autoimmune disease
• People who have had another type of cancer within the past 5 years
• People who are HIV positive, or have active tuberculosis, active hepatitis B, or active hepatitis C
• People with high blood pressure that is not well controlled
• People with poorly controlled blood sugar levels
• People with a history of serious heart or stroke-related conditions
• People who have previously had a stem cell, bone marrow, or organ transplant from another person, or their own stem cell transplant
• People with large or uncomfortable fluid build-up in the body that is not well controlled
• People with a known allergy to the study drugs (SI-B001 or SI-B003) or their ingredients
• People who have had a severe reaction to antibody-based treatments in the past
• Pregnant or breastfeeding women
• People the trial doctor considers unsuitable for other reasons

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