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 are willing to take part voluntarily and agree to follow the study requirements by signing a consent form
• People aged 10 to 80 years old who are generally well enough to carry out normal daily activities with little or no limitation; people aged 80 to 85 may also be considered if a full health assessment shows they are well enough, in the opinion of the trial doctor, and are expected to live more than 3 months
• People who have been diagnosed with colorectal cancer (a type of bowel cancer) that has spread and cannot be removed by surgery, confirmed by laboratory testing of tissue or cells and reviewed by a specialist medical team
• People who have at least one area of cancer that can be measured on a scan, according to standard research measurement guidelines
• People whose blood test results show the blood cells and organs such as the liver, kidneys, and bone marrow are functioning well enough to meet the specific levels required by the trial (confirm with trial site for exact values)
• People whose blood clotting and thyroid hormone levels fall within the ranges required by the trial
• People whose heart is pumping well enough, as measured by an ultrasound scan of the heart
• People who test negative for hepatitis B surface antigen, or if positive, whose hepatitis B virus levels are below a specific threshold set by the trial
• People who test negative for hepatitis C antibodies or hepatitis C virus, or if certain hepatitis C markers are present, whose liver function tests fall within the levels required by the trial (confirm with trial site)
• Women who are past menopause, have had surgery to remove their ovaries and/or uterus, or who could become pregnant but have a negative pregnancy test within 7 days before joining and agree to use highly effective contraception or abstinence for the duration of the study and for at least 6 months after the last dose, and who are not breastfeeding
• Men who agree to abstain from heterosexual intercourse or use a condom throughout treatment and for at least 6 months after the last dose, particularly if their partner could become pregnant or is pregnant

Who may not be able to join:

• People whose colorectal cancer has a specific genetic feature known as MSI-H or dMMR (a marker related to how cancer cells repair DNA)
• People who have been diagnosed with another cancer within the past 3 years, except for certain fully treated cancers such as cervical carcinoma in situ, some skin cancers, or certain early-stage bladder tumours
• People who have difficulty taking oral (swallowed) medication, for example due to trouble swallowing, ongoing diarrhoea, or a bowel blockage
• People who have had gastrointestinal bleeding or a bowel perforation (a hole in the gut wall) within the 4 weeks before joining, or who have a history of this
• People with active inflammatory bowel disease in the 4 weeks before joining
• People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires repeated draining
• People who still have side effects from previous cancer treatment that are more than mild in severity, with the exception of hair loss or certain nerve-related side effects from a specific chemotherapy drug
• People who have had major surgery, a surgical biopsy, or a serious injury within 28 days before the start of study treatment
• People who have had active bleeding symptoms within 1 week before screening that have not improved
• People who have had a significant bleeding event within 4 weeks before starting the study, or who have wounds, ulcers, or fractures that have not healed
• People who have had a blood clot or stroke-related event (including mini-strokes, bleeding in the brain, brain infarction, deep vein thrombosis, or pulmonary embolism) within the past 6 months
• People with a history of misusing mind-altering substances and who are unable to stop
• People with uncontrolled high blood pressure despite medication, serious heart conditions (including certain types of irregular heartbeat, heart attack history, or heart failure), severe or uncontrolled infections, liver cirrhosis or active hepatitis, kidney failure requiring dialysis, HIV or other immune deficiency conditions, a history of organ transplant, poorly controlled diabetes, significant levels of protein in the urine, or neurological or psychiatric conditions such as epilepsy or dementia that require treatment
• People with known active or suspected autoimmune diseases, with some exceptions such as well-managed thyroid conditions or well-controlled type 1 diabetes (confirm with trial site)
• People who have received a live vaccine within 28 days before joining (note: standard inactivated flu vaccines are permitted, but nasal spray live flu vaccines are not)
• People who are taking steroid tablets or other immune-suppressing medicines at higher than low doses within 14 days before joining or during the study, with some exceptions for low-dose or inhaled/topical steroids (confirm with trial site)
• People currently taking part in another clinical trial, or who started another trial's treatment within the past 14 days
• People with a known history of severe allergic reactions to monoclonal antibody medicines
• People who have received surgery, radiotherapy, chemotherapy, or other cancer treatments within 4 weeks before the start of study treatment
• People who have previously received certain targeted anti-cancer drugs after surgery, including bevacizumab, cetuximab, panitumumab, aflibercept, or regorafenib
• People who have cancer that has spread to the brain and is causing symptoms, or whose brain metastasis symptoms have only been controlled for less than 2 months
• People who, in the opinion of the trial doctor, have other health conditions that could put them at serious risk or make it difficult to complete the study

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