Phase 1 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 aged 18 or older
• People with an advanced solid tumour that has been confirmed by laboratory testing of tissue or cells, where standard treatments have failed, could not be tolerated, or no standard treatment options exist
• During the expansion phase of the trial, two specific groups may be enrolled: (1) people with small cell lung cancer (SCLC) who have tried or could not tolerate at least one prior chemotherapy regimen containing platinum; or (2) people with a solid tumour that tests positive for a protein called DLL3, where standard treatments have failed, could not be tolerated, or no standard options exist
• People who have at least one measurable tumour site, as defined by standard medical imaging guidelines (RECIST v1.1)
• People with a general health performance score of 0 or 1 on a standard scale (meaning fully active or able to carry out light activity) — confirm with trial site if unsure
• People with a life expectancy of at least 3 months
• People whose blood test results meet specific minimum requirements for immune cells, platelets, red blood cells, liver function, kidney function, and blood clotting (the trial site will check these)
• People of childbearing potential who are willing to use reliable contraception throughout the study and for 9 months after the last dose; women aged 18–60 must have a negative blood pregnancy test within 7 days before starting
• People who understand the study and are willing to sign a consent form

Who may not be able to join:

• People who have received most forms of systemic cancer treatment (such as chemotherapy, immunotherapy, targeted therapy, or radiotherapy other than palliative bone pain relief) within 4 weeks before starting — shorter timeframes apply for certain oral or traditional Chinese medicines (confirm with trial site)
• People who have used, or would need to use, certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within 2 weeks before starting or during the study
• People who have previously been treated with a type of drug called an antibody-drug conjugate (ADC) that uses a topoisomerase I inhibitor as its active component
• People who have received high-dose steroid treatment or other immune-suppressing medicines within 2 weeks before starting (with some exceptions for inhaled, topical, or low-dose replacement steroids — confirm with trial site)
• People who have received blood transfusions or certain blood cell–stimulating treatments within 2 weeks before starting
• People who have used, or would need to use, medications known to affect heart rhythm (QT-prolonging or shortening drugs) within 7 days before starting, or people with certain heart-related risk factors such as heart failure, low potassium, a personal or family history of a heart rhythm condition called long QT syndrome, or unexplained sudden death in a close family member under age 40
• People with a history of serious heart or stroke-related conditions
• People with a history of a separate primary cancer, unless it was a localised cancer that was fully cured, or unless the person has had no recurrence of the other cancer for 5 or more years
• People with active pneumonia confirmed at screening, or a history of a lung condition called interstitial lung disease
• People with uncontrolled fluid build-up around organs (such as the lungs, abdomen, or heart) that requires frequent draining or ongoing medical management
• People with brain metastases or spinal cord compression at screening, unless local treatment was completed at least 4 weeks before starting, steroids have been stopped for at least 4 weeks, and the condition has been stable for at least 4 weeks
• People with serious unhealed wounds, ulcers, or fractures; or those who had major surgery within 4 weeks before starting; or those planning elective surgery during the study
• People with active hepatitis B or hepatitis C infection, as defined by specific blood test results (the trial site will assess this)
• People with active tuberculosis, or positive test results for tuberculosis antibodies, HIV antibodies, or a history of immune deficiency, organ transplant, or bone marrow transplant
• People with a significant tendency to bleed, a high risk of gastrointestinal bleeding or coughing up blood as assessed by a doctor, or a known inherited bleeding or clotting disorder
• People with an active infection requiring medication, or an unexplained fever of 38.5°C or higher during screening
• People with a history of substance abuse, alcoholism, or drug addiction
• People who are pregnant or breastfeeding at the time of screening
• People with ongoing side effects from previous cancer treatment that have not returned to mild or baseline levels (with some exceptions such as hair loss or nail changes)
• People whom the trial investigator determines are not suitable for participation for any other reason

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