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:

• People who are willing to voluntarily sign a consent form and follow the study requirements
• People of any gender aged 18 to 75 years
• People with a life expectancy of at least 3 months
• People who have been confirmed by laboratory testing (tissue or cell samples) to have squamous cell carcinoma located in the oral cavity, oropharynx, hypopharynx, or larynx
• People who are willing to provide either stored or fresh tumour tissue samples
• People who have at least one tumour that can be measured using standard imaging criteria (known as RECIST v1.1)
• People who are generally able to carry out daily activities with little or no physical limitation (confirm with trial site for exact definition)
• People whose side effects from previous cancer treatments have mostly resolved to a mild level
• People whose heart is pumping blood effectively, with a heart function measurement (LVEF) of 50% or above
• People whose organ function (such as liver and kidneys) meets the required levels set by the trial
• People whose blood clotting levels fall within the required range
• People whose urine protein levels are within the accepted limits
• People of childbearing potential who are willing to use reliable contraception from 7 days before the first dose until 24 weeks after the last dose; women of childbearing potential must have a negative pregnancy blood test within 7 days before starting

Who may not be able to join:

• People whose squamous cell carcinoma started in the nasopharynx, salivary glands, nasal sinuses, or skin, or where the original location of the cancer is unknown
• People taking part in the Phase II portion of the trial who are suitable for and willing to have local treatment, or who have previously received systemic chemotherapy (other than chemotherapy given as part of combined treatment for locally advanced disease)
• People who have cancer that has spread to the brain or spinal cord, or to the lining around the brain or spinal cord
• People who have taken part in another clinical trial within the 4 weeks before starting this study
• People who have received chemotherapy, radiotherapy, immunotherapy, or other cancer treatments within the 4 weeks before starting this study
• People who have had major surgery within the 4 weeks before starting this study
• People who need to take corticosteroids or immune-suppressing medicines on an ongoing basis within 2 weeks before starting the study
• People with significant lung disease rated at a moderate-to-severe level, or who have a current or past history of a condition called interstitial lung disease (ILD)
• People who currently have an active infection that requires treatment through a drip (intravenous antibiotics or antifungals)
• People who previously had serious immune-related side effects (rated Grade 3 or higher) from immunotherapy, or immune-related heart inflammation rated Grade 2 or higher
• People who have received a live vaccine within the 4 weeks before starting the study
• People who have used certain immune-boosting medicines (such as thymosin, interleukin-2, or interferon) within 14 days before starting the study
• People who have, or are at risk of developing, active autoimmune diseases
• People who have had another type of cancer within the 5 years before starting the study
• People who test positive for HIV, active tuberculosis, active hepatitis B, or active hepatitis C
• People with poorly controlled high blood pressure (systolic above 150 mmHg or diastolic above 100 mmHg)
• People with a history of serious heart or stroke-related conditions
• People who have previously received a donor stem cell, bone marrow, or organ transplant
• People with significant or poorly controlled fluid build-up in body cavities (such as around the lungs or abdomen)
• People with a known allergy to recombinant humanised antibodies or to any ingredients in the study drugs (SI-B001 or SI-B003)
• People who have previously had a severe reaction (Grade 3 or higher) to an antibody-based treatment given by infusion
• People who have had any type of stem cell transplant (including their own cells)
• Women who are pregnant or breastfeeding
• People the trial doctors consider unsuitable for any other reason

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