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 at the time of signing the consent form, of any sex.
• People who are willing and able to understand and sign a consent form for the trial.
• People with advanced, returning, or spread-to-other-areas solid tumours that cannot be removed by surgery, confirmed by tissue or cell testing, where standard treatments have either stopped working or caused intolerable side effects, and no standard treatment is currently available. Cancer types include (but are not limited to) small cell lung cancer, glioblastoma (a type of brain tumour), bladder cancer, uterine cancer, cervical cancer, ovarian cancer, breast cancer, and liver cancer.
• People with imaging or tissue test results confirming that their disease has progressed.
• People who have at least one measurable tumour that can be tracked on scans — for glioblastoma, this is measured using a specific brain tumour scale (RANO 2.0); for other solid tumours, a different standard scale is used (RECIST v1.1). Tumours in previously treated areas may qualify if imaging confirms progression after treatment.
• People with glioblastoma who have a functional ability score of 60 or above on a standard scale (KPS). People with other solid tumours who are fully active or have only minor limitations in physical activity (ECOG score of 0 or 1).
• People whose blood test results meet specific minimum thresholds for blood cell counts, kidney function, liver function, blood clotting, and urine protein levels (confirm exact values with the trial site).
• People with an expected survival of at least 12 weeks.
• For the expansion phase of the trial — Cohort 1: People with confirmed small cell lung cancer that has progressed or returned after at least two prior rounds of chemotherapy, including at least one platinum-based treatment.
• For the expansion phase of the trial — Cohort 2: People with confirmed glioblastoma that has progressed or returned after at least one prior course of treatment with a drug called temozolomide.

Who may not be able to join:

• People who received any form of radiation therapy to the brain within 3 months before the first dose.
• People who received any anti-cancer treatment — including chemotherapy, targeted therapy, immunotherapy, cell therapy, radiation (outside the brain rule above), hormone-based cancer treatment, or tumour embolisation — within 28 days before the first dose, or who received a Traditional Chinese Medicine approved for treating cancer within 14 days before the first dose.
• People who have previously been treated with a type of drug called Aurora kinase inhibitors.
• People who used strong drugs known to significantly affect how the body processes certain medications (CYP3A enzyme inducers or inhibitors) within 14 days before the first dose, or who are still within a defined clearance window for such drugs (whichever is longer).
• People with glioblastoma who were taking more than 5 mg per day of dexamethasone (or an equivalent steroid dose) within 1 week before the first dose.
• People who had major surgery (brain, chest, or abdominal) within 28 days before the first dose, or who have wounds, ulcers, or fractures that have not fully healed.
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild level, except for hair loss or lab abnormalities considered medically unimportant by the doctor.
• People who have had another primary cancer within the past 5 years, except for certain treated skin cancers or in situ (non-spreading) cancers as assessed by the trial site.
• People with other solid tumours (not glioblastoma) who have unstable brain metastases. Stable brain metastases may be permitted if no local treatment is planned, there are no neurological symptoms, and the brain lesions have been stable for at least 2 weeks without steroids or anti-seizure medication.
• People with cancer spread to the membranes lining the brain or spinal cord (leptomeningeal metastasis), except those with glioblastoma.
• People with severe brain herniation or who are at significant risk of it.
• People with glioblastoma who had a drug-releasing wafer implanted in the brain during surgery.
• People who had fluid drained from the chest, abdomen, or around the heart within 1 month before the first dose, or who have significant related symptoms such as chest tightness or breathlessness.
• People with significant or uncontrolled heart problems, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past 6 months, serious heart rhythm problems, low pumping function of the heart, certain types of heart muscle disease, coronary artery disease requiring medication, abnormal heart electrical readings beyond defined limits, a significant stroke or mini-stroke within 6 months, poorly controlled blood pressure, or use of three or more blood pressure medications.
• People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L).
• People with significant digestive system problems that may affect how the trial drug is swallowed or absorbed, such as difficulty swallowing, chronic diarrhoea, bowel blockage, or having had major bowel or stomach surgery.
• People who have had significant coughing up of blood or tumour bleeding within 14 days before the first dose, significant active bleeding within 2 months before the first dose, or who are currently on blood-thinning medications (such as warfarin; low-dose aspirin and preventive heparin may be allowed). People with a high risk of bleeding, such as from certain vein or stomach conditions, are also excluded.
• People who have had a serious blood clot event — such as a clot in an artery, lung, or deep vein — within 6 months before the first dose. Minor or stable clots related to medical devices may not be excluded (confirm with trial site).
• People who have an active infection requiring treatment through a drip (intravenous antibiotics) at the time of screening, or who had a serious infection within 28 days before the first dose. People on preventive antibiotics may still be eligible.
• People with known active tuberculosis, currently being treated for it, or who completed tuberculosis treatment within the past year.
• People with active hepatitis B or hepatitis C, where the virus is actively replicating in the body.
• People with HIV infection or active syphilis infection confirmed by blood tests.
• People with a known allergy or sensitivity to the trial drug or any of its ingredients, or a history of severe allergic conditions.
• People who have had an organ transplant or a bone marrow/stem cell transplant from another person.
• People with a history of alcohol or drug misuse.
• People with a psychiatric or cognitive condition that may prevent them from understanding the consent process or following the trial requirements.
• Women who could become pregnant and who are unwilling or unable to use effective contraception throughout the treatment period and for 3 months after the last dose. Male participants whose partners could become pregnant must also use effective contraception during this time. Pregnant or breastfeeding women are not eligible.
• People whom the trial doctors consider unsuitable for any other reason.

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