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 aged 18 to 75 years old, of any gender
• People who have been diagnosed through a biopsy with head and neck squamous cell carcinoma that has come back or spread, and for whom major surgery or combined chemotherapy and radiation treatment is not an option
• For the combination treatment group: People who have not previously had systemic (whole-body) anti-cancer treatment, or whose cancer came back at least 6 months after completing earlier pre- or post-surgery treatment
• For the immunotherapy-only group: People who have not previously received immunotherapy; those without prior systemic treatment must have a specific protein marker called PD-L1 confirmed positive by a central laboratory, while those with prior systemic treatment have no restriction on this marker
• People who have at least one tumour that can be measured on a CT or MRI scan, according to standard medical measurement guidelines
• People whose general physical fitness and ability to carry out daily activities meets a standard medical score of 0 or 1 (meaning fully active or restricted in strenuous activity only)
• People with a life expectancy of at least 3 months
• People whose major organ function (such as liver, kidneys, and blood counts) meets the required levels within 7 days before starting the trial
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose, and all participants must agree to use effective contraception from signing the consent form until 7 months after the last dose; women must not breastfeed during this period, and men must not donate sperm
• People who are willing to take part voluntarily, understand what the study involves, and are able to sign a written consent form

Who may not be able to join:

• People whose cancer started in the nasopharynx, salivary glands, sinuses, or skin, or where the original cancer site is unknown; also people whose cancer has features of neuroendocrine carcinoma, mesenchymal tumours, or carcinosarcoma on biopsy
• People with cancer that has spread to the membranes around the brain, the brainstem, the spinal cord, or that is actively growing in the brain; people with certain brain metastases that have been treated and have been stable for at least 2 weeks may be considered (confirm with trial site)
• People who have had another type of cancer within the past 3 years, except for certain treated skin cancers, superficial bladder cancer, or early-stage prostate or cervical cancers that are considered cured
• People known to be allergic to any ingredient in the trial drugs (SYS6010 or Enlonstobart) or to similar antibody-based medicines
• People who still have side effects from previous cancer treatment that have not improved to a mild level, with some exceptions such as certain types of hair loss or nerve-related effects (confirm with trial site)
• People who have previously received certain types of systemic anti-cancer treatment for a specific type of lung cancer other than a targeted therapy called EGFR TKI (confirm with trial site)
• People who have not completed the required waiting period after certain previous treatments or medications (confirm with trial site for specific timeframes)
• People who have had a serious heart or stroke-related event within the 6 months before starting the trial
• People whose scans show the tumour is growing into or involving major blood vessels in the neck, chest, or abdomen
• People who have a history of, or currently have, a lung condition called interstitial lung disease or non-infectious pneumonitis, or whose lung function tests show severe breathing or oxygen-transfer problems
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting the trial, or an active infection requiring antibiotic treatment within 2 weeks before starting
• People who previously had to stop a targeted skin therapy called EGFR treatment for a month or more due to skin reactions, or who currently have a skin condition requiring oral or intravenous medication
• People with active autoimmune diseases or a history of certain autoimmune conditions such as ulcerative colitis or Crohn's disease; people with well-controlled type 1 diabetes or thyroid conditions managed only with hormone replacement may still be considered (confirm with trial site)
• People who needed medical treatment for fluid around the lungs or heart within 2 weeks before starting the trial
• People with active hepatitis B or hepatitis C infection based on blood test results above certain levels; people with hepatitis B surface antigen positive results may be able to participate if they start antiviral treatment before the trial begins (confirm with trial site)
• People with a history of immune system deficiency, including HIV infection, other inherited or acquired immune conditions, or a history of stem cell or organ transplant
• People who the trial doctors consider unsuitable for other reasons, such as certain mental health conditions, eye disorders, or poorly controlled blood pressure or diabetes

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