Phase 1 Head and Neck Cancer Trial, Recruiting

Written by an AI model from the 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
• People 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 diagnosed with locally advanced or metastatic head and neck squamous cell carcinoma or certain other solid tumour cancers
• People who are willing to provide either stored tumour tissue or a fresh tissue sample taken within the past 3 years
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1)
• People whose general health and ability to carry out daily activities meets a specific standard (rated 0 or 1 on the ECOG scale, meaning fully active or able to carry out light activity)
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better
• People with no serious heart function problems and a heart pumping function of at least 50%
• People whose organ function (such as liver, kidneys, and blood counts) meets the required levels set by the trial
• People whose blood clotting test results fall within the acceptable range for the trial
• People whose urine protein levels fall within the acceptable range for the trial
• People who are able to use reliable contraception throughout treatment and for 6 months after treatment ends, and whose pregnancy test (if applicable) is negative within 7 days before starting treatment

Who may not be able to join:

• People who have received chemotherapy, biological therapy, or immunotherapy within 4 weeks (or within 5 half-lives of the drug) before the first dose
• People with a history of serious heart disease
• People with certain heart rhythm abnormalities, including prolonged QT interval, complete left bundle branch block, or third-degree heart block
• People with active autoimmune or inflammatory diseases
• People diagnosed with another cancer within the past 5 years before the first dose
• People with high blood pressure that remains poorly controlled despite taking two blood pressure medications
• People with poorly controlled blood sugar levels
• People who have had unstable blood clotting events requiring treatment within the past 6 months
• People with significant lung disease rated at a serious level (Grade 3 or higher on the CTCAE scale)
• People with active symptoms caused by cancer that has spread to the brain or central nervous system
• People with a known allergy to certain types of antibody-based medicines or to any ingredient in the study drug BL-M24D1
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• People who have received a high cumulative dose of a specific type of chemotherapy drug (anthracycline) exceeding 360 mg/m² in past treatment
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
• People with a history of a lung condition called interstitial lung disease (ILD) that required steroid treatment, or who currently have ILD
• People who have had an active infection requiring treatment within 4 weeks before the first dose, or a lung infection within 2 weeks before the first dose
• People who have had fluid build-up around the lungs, abdomen, pelvis, or heart requiring drainage or causing symptoms within 4 weeks before the first dose
• People who have had significant bleeding or a clear tendency to bleed within 4 weeks before the first dose
• People who have taken part in another clinical trial within 4 weeks before the first dose
• People who are pregnant or breastfeeding
• People who the trial doctor considers unsuitable for participation for other medical reasons (confirm with trial site)

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