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 who are willing to sign a consent form and follow the study requirements
• People of any gender aged 18 to 75 years (for Phase Ia of the study) or aged 18 and older (for Phase Ib of the study)
• People with a life expectancy of at least 3 months
• People who have been diagnosed with returning or spreading head and neck squamous cell cancer, or other solid tumour cancers, confirmed by laboratory testing, where standard treatments have not worked or are not an option
• People who are willing to provide stored tumour tissue samples (from within the past 3 years) 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 with a good general level of physical functioning, rated 0 or 1 on a standard scale used by doctors (ECOG scale)
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or lower
• People with no serious heart problems and whose heart pumping function is at least 50% (as measured by a standard heart scan)
• People whose blood counts and organ function meet required levels, without needing a blood transfusion or blood-stimulating medication in the 14 days before screening
• People whose blood clotting results fall within acceptable ranges specified by the trial
• People with a urine protein level within the limits specified by the trial
• Women of childbearing age who test negative for pregnancy within 7 days before starting the trial and who are not breastfeeding; all participants, regardless of gender, must use adequate contraception during treatment and for 6 months after treatment ends

Who may not be able to join:

• People who have received certain cancer treatments within 4 weeks or 5 half-lives before the first dose, or specific chemotherapy drugs (mitomycin or nitrosoureas) within 6 weeks, or certain oral cancer medicines such as fluorouracil
• People with a history of serious heart disease
• People with certain heart rhythm problems, including a prolonged QT interval, complete left bundle branch block, or a severe type of heart conduction block (third-degree atrioventricular block)
• People with active autoimmune or inflammatory diseases
• People diagnosed with another type of cancer within the past 5 years before joining the trial
• People with high blood pressure that is not well controlled even with two blood pressure medicines (readings above 150/100 mmHg)
• People with poorly controlled blood sugar levels
• People with current or previous lung inflammation related to radiation therapy, or a current or past diagnosis of a lung condition called interstitial lung disease (ILD), or suspected ILD
• People with lung disease that causes serious breathing difficulties
• People with active symptoms related to cancer that has spread to the brain or central nervous system
• People with a known allergy to similar types of antibody-based medicines or to any ingredient in the study drug (BL-B16D1)
• People who have previously had an organ transplant or a stem cell transplant from a donor
• People who have previously received a high cumulative dose of a type of chemotherapy called anthracyclines (above 360 mg/m²)
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
• People who had a serious infection within 4 weeks before the first dose, or signs of a lung infection within 2 weeks before the first dose
• People with large or symptomatic fluid build-up in the body that is not well controlled
• People who have taken part in another clinical trial within 4 weeks before the first dose
• People with certain eye conditions, including active eye infection, corneal ulcer, vision in only one eye, a history of corneal transplant, dependence on contact lenses, uncontrolled glaucoma, or uncontrolled or worsening retina problems or wet macular degeneration
• People considered unsuitable for the trial by the medical team for any other reason

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