Phase 2 Lung 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 generally able to care for themselves and carry out light activity (a performance scale score of 0 or 1, confirm with trial site)
• People who have been diagnosed with extensive-stage small cell lung cancer confirmed by laboratory testing of tissue or cell samples
• People in Cohort A: those with extensive-stage small cell lung cancer whose cancer has stopped responding to, or who could not tolerate, 3 or more previous cancer treatments
• People in Cohort B (Stage I): those with extensive-stage small cell lung cancer whose cancer has stopped responding to, or who could not tolerate, standard previous treatment
• People in Cohort B (Stage II): those with extensive-stage small cell lung cancer who have not yet received any systemic (whole-body) cancer treatment
• People who are able to provide stored tumour tissue samples or fresh tumour samples taken within the last 3 years (those who cannot provide samples may still be considered at the investigator's discretion)
• People who have at least one tumour that can be measured on scans, as defined by standard measurement guidelines (RECIST v1.1)
• People whose blood, kidney, liver, clotting, heart, and urine test results meet the minimum levels required by the trial (confirm specific values with trial site)
• People whose side effects from previous cancer treatments have largely resolved to a mild level before joining
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment and must not be breastfeeding; all participants must use reliable barrier contraception throughout treatment and for 6 months after treatment ends

Who may not be able to join:

• People who have previously been treated with EGFR or HER3 monoclonal antibody drugs
• People who have received chemotherapy, immunotherapy, biological therapy, targeted therapy, major surgery, or definitive radiotherapy within 4 weeks (or 5 half-lives of the drug, whichever is shorter) before the first dose; or certain oral chemotherapy drugs or palliative radiotherapy within 2 weeks before the first dose
• Cohort B (Stage II) only: people who have previously received any systemic cancer treatment for extensive-stage small cell lung cancer
• Cohort B only: people who have had a serious immune-related side effect (grade 3 or higher) from previous immunotherapy, or immune-related heart inflammation (grade 2 or higher)
• Cohort B only: people who have used certain immune-boosting medicines (such as thymosin, interleukin-2, or interferon) within 14 days before the first dose
• People with a history of serious heart or blood vessel conditions, including severe abnormal heart rhythms, certain heart conduction problems, a prolonged electrical interval in the heart on ECG, heart attack, unstable chest pain, heart surgery or stents, severe heart failure, stroke, or mini-stroke within the past 6 months
• People with active autoimmune or inflammatory conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, or psoriasis requiring whole-body treatment (some controlled conditions such as type 1 diabetes and managed thyroid conditions may not exclude a person — confirm with trial site)
• People who have had another cancer that has been active or required treatment within the past 5 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 poorly controlled high blood pressure, or a history of hypertensive crisis or hypertensive brain injury
• People who have had a blood clot in a deep vein, artery, or lung that required medical treatment within the past 6 months
• People who currently have active or unstable cancer spread to the brain or to the lining around the brain (some people with previously treated, stable, small brain metastases may be considered — confirm with trial site); people with cancer spread to the lining of the brain are excluded even if treated
• People who have fluid build-up around the lungs, heart, or abdomen that is causing symptoms or needs to be repeatedly drained
• People who have had an allergic reaction to humanised or human-mouse antibody medicines, or to any ingredient in the study drug (BL-B01D1)
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• People who are HIV positive, have active tuberculosis, or have active hepatitis B or hepatitis C infection
• People who have an active infection that requires systemic (whole-body) treatment, such as severe pneumonia or blood infection
• People who have taken part in another clinical trial within the 4 weeks before the first dose
• People with a history of substance misuse involving psychotropic drugs that cannot be managed, or people with a mental health disorder that the trial team considers would affect participation
• People whom the investigator considers unsuitable for the trial for any other reason

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