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 voluntarily agreed to take part and have signed a consent form
• Adults aged 18 to 75 years (male or female)
• People whose doctors estimate they are likely to live for at least 3 more months
• People who are fairly active and able to care for themselves, with only mild limitations on physical activity (as measured by a standard medical scale called ECOG, scoring 0 or 1)
• People who have been diagnosed with a returning or spreading type of head and neck cancer called squamous cell carcinoma (not including nasopharyngeal carcinoma), confirmed by laboratory testing of tissue or cells — either those who have already tried at least one round of treatment that did not work or was not tolerated (certain groups), or those who have not yet received any systemic treatment for the returning or spreading cancer (one specific group)
• People who are able to provide stored tumour tissue samples or fresh tissue samples taken within the last 3 years — if samples cannot be provided, the trial site may still consider enrolment on a case-by-case basis
• People who have at least one measurable area of cancer, as defined by a standard measurement guideline called RECIST v1.1
• People whose blood, kidney, liver, clotting, and heart function results meet specific levels set by the trial (no blood transfusions or certain growth-factor medicines in the 14 days before screening)
• People whose side effects from any previous cancer treatment have mostly resolved to a mild level or lower, with some specified exceptions allowed
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, must not be breastfeeding, and all enrolled participants must use reliable barrier contraception throughout treatment and for 6 months after it ends

Who may not be able to join:

• People who have previously been treated with a type of drug called an ADC that uses a topoisomerase I inhibitor as its active component
• People who have received cancer treatments such as chemotherapy, immunotherapy, radiotherapy, major surgery, or targeted therapy within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before the first study dose; or certain oral chemotherapy medicines or palliative radiotherapy within 2 weeks before the first dose
• People whose cancer has been confirmed by testing to be a non-squamous cell type
• People in one specific trial group (Cohort C Stage II) who have already received systemic treatment for their returning or spreading head and neck cancer (not counting certain earlier chemotherapy before surgery or after surgery)
• People in certain trial groups who have a history of serious immune-related side effects (grade 3 or higher, or grade 2 or higher immune-related heart inflammation) from previous immunotherapy
• People in certain trial groups who have taken immune-modulating medicines (such as thymosin, interleukin-2, or interferon) within 14 days before the first study dose
• People who need to take moderate-to-high doses of steroid medicines by mouth or injection within 2 weeks before the first dose (inhaled, topical, or low replacement doses may be acceptable)
• People with a history of serious immune-related side effects (grade 3 or higher, or grade 2 or higher immune-related heart inflammation) from any previous immunotherapy
• People with a history of serious heart or blood vessel problems, including dangerous heart rhythm problems, a prolonged QT interval on a heart tracing, heart attack, unstable chest pain, heart failure (NYHA class III or IV), stroke, or mini-stroke within 6 months before the first dose
• People with active autoimmune or inflammatory conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, or psoriasis requiring systemic treatment (some conditions that are well-controlled, such as hypothyroidism or type 1 diabetes, may be acceptable — confirm with trial site)
• People who have had another cancer that has been active or required treatment within the past 3 years, with some exceptions for certain early-stage or fully treated cancers (confirm with trial site)
• People with a history of lung inflammation (interstitial lung disease) that required steroid treatment, or who currently have or are suspected to have this condition
• People with poorly controlled diabetes or high blood pressure, or a history of hypertensive crisis or hypertensive brain injury, before starting the study
• People who have had blood clots in deep veins, arteries, or lungs requiring medical treatment within 6 months before screening (clots related to IV lines may be excepted — confirm with trial site)
• People with cancer that has spread to the brain or the lining of the brain (meningeal metastases) — those with previously treated and stable brain metastases that have been stable for at least 28 days without steroids may be considered, but meningeal metastases are excluded regardless of treatment status
• People with fluid build-up around the lungs, heart, or abdomen that is causing symptoms or needs to be drained repeatedly
• People with a known allergy to the type of antibody used in the study drug (BL-B01D1) or to any of its ingredients
• People who have had an organ transplant or a stem cell transplant from a donor
• People who are HIV positive, have active tuberculosis, or have active hepatitis B or C infection
• People with active serious infections requiring systemic treatment, such as severe pneumonia or blood infection
• People who have taken part in another clinical trial within 4 weeks before the first study dose
• People with a history of substance abuse involving psychotropic drugs that cannot be stopped, or who have a mental disorder that the trial site considers would affect participation
• People who the trial investigators consider unsuitable for the trial for any other reason

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