Phase 2 Colorectal 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 signed a written consent form agreeing to take part.
• Adults aged 18 or older, of any gender.
• People who are relatively well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1 — confirm with trial site).
• People who have been diagnosed with colorectal cancer that has spread to other parts of the body (metastatic), confirmed by laboratory testing of tissue or cell samples, and who have been treated with no more than 2 previous chemotherapy regimens for the metastatic disease (with specific rules about how prior treatments are counted — confirm with trial site).
• People whose tumour tissue tests positive for a protein called LGR5, at any level.
• People whose cancer can be measured or tracked using standard imaging methods, including those with limited spread to the lungs, provided the lung involvement does not block important structures (confirm with trial site for cases involving more than 20% of both lung fields).
• People with a life expectancy of more than 12 weeks.
• People whose liver, kidneys, and bone marrow are functioning normally.
• People with no significant abnormalities found in urine testing at the screening stage.
• People with no significant bowel disease in the 28 days before joining the trial.
• People who do not currently need anti-diarrhoea medication on an ongoing basis.
• Women who could potentially become pregnant must have a negative blood pregnancy test within 72 hours before receiving the trial treatment.
• People of childbearing potential, and male participants whose partners could become pregnant, must agree to use a highly effective form of contraception during the trial and for 6 months after the last dose of trial treatment.

Who may not be able to join:

• People who are unlikely to be able to follow the study procedures or attend follow-up appointments.
• Women who are pregnant or currently breastfeeding.
• People whose colorectal cancer has a specific genetic change called a BRAF mutation.
• People who have already received certain specific medications — trifluridine/tipiracil (TAS-102) or regorafenib — for their metastatic disease.
• People who have had chemotherapy, hormone therapy, immunotherapy, biological therapy, or radiation therapy for their cancer within 4 weeks before the planned start of a preparatory treatment step called lymphodepletion.
• People who have taken part in another clinical trial using an experimental treatment within the 28 days before joining.
• People who have received antibody-based treatments within 28 days, or within 5 half-lives of that treatment (whichever is the shorter period — confirm with trial site).
• People who have had major surgery within 4 weeks before joining.
• People who have had a build-up of fluid around the lungs (pleural effusion) that needed draining in the 4 weeks before joining.
• People with any uncontrolled medical or mental health condition that could make receiving the trial treatment unsafe or prevent them from giving informed consent.
• People with known cancer that has spread to the brain or central nervous system.
• People currently taking medications that may affect the heart's electrical rhythm in a specific way (QTc prolongation — confirm with trial site).
• People with an active bacterial, viral, or fungal infection that requires treatment.
• People with a known infection with HIV, Hepatitis B, Hepatitis C, or liver cirrhosis.
• People who are unable to have blood drawn through a vein or cannot tolerate venous access.
• People who have had another cancer in the past 5 years, with some exceptions for certain low-risk, successfully treated cancers (confirm with trial site).
• People with an active autoimmune disease that is not adequately controlled by standard low-level treatments such as anti-inflammatory drugs or low-dose steroids.
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis, whether active or past) or active stomach ulcers.
• People with a history of connective tissue disorders (such as lupus or scleroderma — confirm with trial site).
• People with a history of chronic leukaemia.
• People who have previously had radiation therapy covering the whole abdomen or pelvis, or who have more than mild ongoing side effects from any previous radiation therapy.
• People with significant heart risks, including having had a heart stent or heart attack in the past year.
• People whose heart pumping function is below 50% (as measured by a cardiac test — confirm with trial site).
• People who have had a blood clot in a vein (such as deep vein thrombosis or pulmonary embolism) and are currently taking blood-thinning medication.
• People with a heart rhythm condition involving a prolonged QT interval, whether inherited or developed.
• People with a history of certain lung conditions, including interstitial lung disease, pulmonary fibrosis, sarcoidosis, or hypersensitivity pneumonitis, or those with multiple allergies.
• People who have fluid in the abdomen (ascites), have had that fluid drained previously, or have significant cancer deposits on the lining of the abdomen.
• People with reduced liver function or risk of liver complications, including those with portal hypertension, liver surgery in the past 6 months, existing or planned bile duct stents, gallstones, alcohol or paracetamol overuse, use of herbal medicines, or substance misuse.

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