Phase 2 Lung 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 aged 18 to 75 years old
• People with a life expectancy of at least 3 months
• People who have been diagnosed with non-small cell lung cancer that cannot be surgically removed and has either spread locally or to other parts of the body, confirmed by a tissue or cell sample
• People whose cancer has a known HER2 gene mutation, confirmed by previous or trial site testing
• People whose advanced cancer has already been treated with platinum-based chemotherapy and immunotherapy (either together or one after the other), and whose cancer has either gotten worse during or after that treatment, or who cannot tolerate standard treatment
• People who are able to provide a stored or fresh tumour tissue sample taken within the last 2 years for testing (those unable to provide a sample may still be considered after review by investigators)
• People who have at least one tumour that can be measured on scans, as defined by standard medical criteria (RECIST v1.1)
• People who are in generally good physical condition, able to carry out everyday activities with little or no restriction (ECOG score 0 or 1)
• People whose side effects from previous cancer treatments have largely resolved to a mild level or better
• People with no serious heart problems and with a heart pumping function of at least 50%
• People whose organ function (such as liver and kidney) meets the required levels for the trial
• People with normal blood clotting levels within the ranges specified by the trial
• People with a low level of protein in their urine
• Women of childbearing age who have a negative pregnancy test within 7 days before starting the study and who are not breastfeeding; all participants are advised to use reliable contraception throughout treatment and for 6 months after finishing

Who may not be able to join:

• People who have received chemotherapy, immunotherapy, biological therapy, or other cancer treatments within 4 weeks (or 5 half-lives) before the first dose — or within 6 weeks for certain specific drugs
• People who have previously been treated with a type of cancer drug called an ADC (antibody-drug conjugate) that uses a camptothecin-based component
• People whose cancer has other specific gene mutations that are targeted by other drugs (confirm with trial site)
• People with a history of serious heart or stroke-related conditions
• People with active autoimmune or inflammatory diseases
• People who have had another type of cancer within the past 5 years
• People who have had serious blood clot conditions (such as deep vein thrombosis, arterial clots, or pulmonary embolism) requiring medical treatment within the 6 months before the screening visit
• People with poorly controlled fluid build-up around the heart, lungs, abdomen, or pelvis that is causing symptoms, as assessed by the investigator
• People with high blood pressure that remains poorly controlled despite medication (above 150/100 mmHg)
• People with current or past lung inflammation conditions such as interstitial lung disease or radiation pneumonitis that required steroid treatment
• People with cancer that has spread to the brain or the lining around the brain
• People with a known allergy to the study drug (BL-M07D1) or similar types of antibody-based treatments
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• People with HIV, active tuberculosis, active hepatitis B, or active hepatitis C infection
• People with active infections that require systemic treatment, such as severe pneumonia or sepsis
• People who have taken part in another clinical trial within 4 weeks before the first dose
• Women who are pregnant or breastfeeding
• People who the investigator considers unsuitable for the trial for any other reason

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