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 have chosen to take part voluntarily and have signed a consent form
• Adults aged 18 to 75 years (male or female)
• People whose doctors expect them to live for at least 3 more months
• People who are fully active or have only minor restrictions on physical activity (confirm with trial site for exact fitness level required)
• People diagnosed with head and neck squamous cell carcinoma (not nasopharyngeal carcinoma) that has come back or spread, or other solid tumours, confirmed by laboratory testing of tissue or cells
• People who can provide a tumour tissue sample taken within the last 3 years for laboratory testing
• People who have at least one tumour that can be measured using standard imaging criteria
• People who have not had a blood transfusion or certain blood-boosting medications in the 14 days before screening, and whose organ function meets required levels
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better
• Women of childbearing potential who test negative for pregnancy within 7 days before starting treatment, are not breastfeeding, and are willing to use reliable contraception throughout treatment and for 6 months after treatment ends (this applies to all enrolled participants)

Who may not be able to join:

• People who have previously been treated with a certain type of antibody-drug combination therapy that uses TOP I inhibitors (confirm with trial site)
• People who have received anti-cancer treatment within 4 weeks (or 5 half-lives) before the first dose, or palliative radiation therapy within 2 weeks before the first dose
• People who have already received systemic anti-cancer treatment for recurrent or metastatic head and neck squamous cell carcinoma or similar solid tumours
• People who have previously had immunotherapy and experienced serious immune-related side effects, including severe immune reactions (grade 3 or higher) or moderate to severe immune-related heart inflammation (grade 2 or higher)
• People who have used immune-modifying medications within 14 days before the first dose
• People who needed regular steroid medications within 2 weeks before the first dose
• People with a history of serious heart or blood vessel disease
• People with active autoimmune or inflammatory conditions
• People who have had another cancer that was active or being treated within the 3 years before joining
• People with a lung condition called interstitial lung disease (ILD), either currently, suspected, or previously treated with steroids
• People with poorly controlled diabetes or high blood pressure, or a history of hypertensive crisis or hypertensive encephalopathy
• People who have had an unstable blood clot event requiring treatment within the 6 months before screening
• People with cancer that has actively spread to the brain or spinal cord
• People with significant fluid build-up around the lungs, heart, or in the abdomen that causes symptoms or needs repeated draining
• People with a known allergy to certain types of engineered antibodies or to any ingredient in the study drug (BL-B01D1)
• People who have had an organ transplant or a bone marrow transplant from a donor
• People who are HIV positive, or have active tuberculosis, active hepatitis B, or active hepatitis C
• People with an active infection currently requiring treatment with systemic medications
• People who have taken part in another clinical trial within 4 weeks before the first dose
• People with a history of substance abuse involving psychotropic drugs that cannot be stopped, or people with a diagnosed mental disorder
• People the trial investigators consider unsuitable for any other reason

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