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, of any gender, who are able to read, understand, and sign a consent form agreeing to take part in the study
• People who have been diagnosed with a solid tumour (confirmed by laboratory analysis of tissue or cell samples) that cannot be removed by surgery and has either spread to nearby areas or to other parts of the body
• People who have at least one tumour that can be assessed or measured on scans, confirmed within 28 days before the first dose of the study drug
• People whose general physical fitness is rated at a level of 0 or 1 on a standard oncology fitness scale, meaning they are either fully active or have minor restrictions on strenuous activity but can carry out light work (confirm with trial site)
• People whose doctors expect them to live for at least 12 weeks
• People whose blood counts are at acceptable levels, without having received blood-boosting injections or transfusions in the 7 days before starting the study
• People whose liver is functioning at an acceptable level based on blood tests
• People whose kidneys are functioning at an acceptable level based on blood and urine tests
• People whose heart is pumping effectively (at least 50% efficiency) with no significant heart rhythm problems or fluid around the heart
• People whose blood clotting levels fall within an acceptable range
• People who have at least a minimal level of lung function, with no significant breathlessness and blood oxygen levels of 95% or above while breathing normal air
• People who are not able to have children, or who agree to use at least one highly effective method of contraception from the start of screening until 7 months after the last dose (for females) or 4 months after the last dose (for males)

Who may not be able to join:

• People who are currently taking part in another interventional clinical trial, or who are still in the follow-up period of a previous interventional trial
• People who have recently received certain cancer treatments before starting the study, including chemotherapy, immunotherapy (such as PD-1/PD-L1 drugs), targeted therapy, radiation therapy, or cell-based therapies, within specific timeframes before the first dose (confirm exact timeframes with trial site)
• People who have received a live vaccine within the past 4 weeks, or a cancer vaccine within the past 3 months, or who plan to receive a live vaccine during the study
• People who have taken strong inhibitors of a specific liver enzyme (CYP3A4) within 2 weeks or 5 half-lives before the first dose, whichever is shorter (confirm with trial site)
• People who still have significant side effects from previous cancer treatments that have not returned to a mild or baseline level, with some exceptions such as hair loss or fatigue
• People with a known allergy or sensitivity to the study drug (IBI3028) or any of its ingredients
• People who have had major surgery (such as surgery on the brain, chest, or abdomen) within the past 4 weeks, or who have serious unhealed wounds or ulcers
• People with brain or spinal cancer spread that is currently causing symptoms; those with small, stable, symptom-free brain metastases may be considered under specific conditions (confirm with trial site)
• People with active, uncontrolled infections requiring ongoing antibiotic, antiviral, or antifungal treatment
• People with HIV infection that is not well controlled (specific rules apply depending on the country; confirm with trial site)
• People with active hepatitis B or hepatitis C infection at levels above certain thresholds
• People with active tuberculosis, or who have been treated for tuberculosis within the past year
• People with uncontrolled heart conditions, including heart muscle inflammation, moderate-to-severe heart failure, uncontrolled irregular heartbeat, a specific heart rhythm measurement (QTc interval) above 480 ms, or a personal or family history of certain inherited heart rhythm conditions
• People with high blood pressure that remains uncontrolled despite standard treatment
• People who currently have a stent in the digestive tract or airway
• People with significant malnutrition requiring nutrition delivered directly into a vein
• People with spinal cord compression that has not been fully treated with surgery or radiation
• People with fluid build-up around the lungs, abdomen, or heart that requires active medical intervention
• People with a history of lung inflammation that required steroid treatment, or significant lung diseases such as scarring of the lung tissue or uncontrolled lung conditions
• People who have had a serious artery-related event (such as a heart attack, stroke, or mini-stroke) within the past 6 months
• People with abnormal veins in the oesophagus or stomach that are at high risk of bleeding or require immediate treatment; some people with signs of related conditions may need an endoscopy before joining (confirm with trial site)
• People who have had a life-threatening bleed, or a bleed requiring transfusion, endoscopy, or surgery, within the past 3 months
• People with unresolved blockages, tears, or abnormal connections in the digestive tract, or who have had significant bowel surgery, active inflammatory bowel disease, or ongoing moderate-to-severe diarrhoea
• People with a history of immune system deficiency, whether present from birth or developed over time
• People who have had an organ transplant or bone marrow transplant from another person, or their own stem cell transplant within the past 3 months (corneal transplants are an exception)
• People who have had another type of cancer within the past 2 years, with some exceptions for certain low-risk or fully treated cancers (confirm with trial site)
• People who currently have an indwelling tube or drain in place, such as a kidney, bile, or abdominal drainage tube (certain central venous access devices are permitted; confirm with trial site)
• People with other significant medical conditions or abnormal test results that, in the treating doctor's judgment, would make participation unsafe or affect the trial results
• People with neurological, mental health, or social circumstances that would make it difficult to follow the trial requirements or safely give informed consent
• People who are pregnant, have a positive pregnancy test, or are currently breastfeeding
• People considered by the treating doctor to be unsuitable for any other reason

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