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 fully understand what the study involves, including possible side effects, and have signed a consent form agreeing to take part and follow the study requirements
• People aged 18 to 75 years at the time of signing the consent form, of any sex
• People who have been confirmed through laboratory tissue testing to have advanced colorectal cancer
• People whose colorectal cancer has spread locally or to other parts of the body, and whose cancer has stopped responding to, progressed through, or caused severe side effects from at least one standard treatment, or who cannot have standard treatment and are not suitable for curative treatment
• People who have at least one tumour that can be measured on a scan, assessed within 4 weeks before joining the trial
• People who can provide a stored tumour tissue sample (preferably from within the last 2 years) or who agree to have a new biopsy taken to test for a protein called PD-L1
• People who have waited the required amount of time since their last treatment before starting the trial — specific waiting periods apply depending on the type of previous treatment (confirm with trial site), and any side effects from past treatment must have largely resolved
• People who have a good general level of physical functioning, rated 0 or 1 on a standard scale, assessed within 1 week before joining
• People with a life expectancy of more than 3 months
• People whose blood test results show their organs are functioning adequately, tested within 1 week before joining (no blood transfusions or certain blood-boosting injections allowed in the 14 days before the first dose)
• People of childbearing potential who agree to use at least one highly effective form of contraception during the trial and for at least 6 months after the last dose; women of childbearing age must have a negative pregnancy test within 7 days before enrolling

Who may not be able to join:

• People who had curative-intent radiation therapy within 3 months before the first dose
• People who have had another cancer diagnosed within the past 2 years, except for certain early-stage cancers that have been fully treated (such as some skin cancers, early cervical, prostate, breast, or thyroid cancers — confirm with trial site)
• People who had to permanently stop immunotherapy in the past due to side effects, or who experienced certain serious immune-related lung or heart inflammation during prior immunotherapy
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining
• People with active and significant gastrointestinal bleeding
• People with spinal cord compression, active or symptomatic cancer spread to the brain or the lining of the brain — though people who have previously been treated for brain metastases and have been stable for at least 4 weeks with no signs of progression may potentially be considered (confirm with trial site)
• People with significant ongoing lung problems, including certain lung diseases, autoimmune conditions affecting the lungs, a history of having a whole lung removed, or radiation-related lung inflammation within the past 6 months (confirm with trial site for full list)
• People with poorly controlled heart or blood vessel conditions, including moderate-to-severe heart failure, unstable chest pain, a heart attack or stroke within the past 6 months, poorly controlled heart rhythm problems, or high blood pressure that remains uncontrolled despite treatment
• People with an active serious infection requiring intravenous antibiotics, or active tuberculosis, within 2 weeks before joining
• People who have taken certain medications that affect how the liver processes drugs (moderate or potent CYP2D6 or CYP3A inhibitors or inducers) within 2 weeks before joining (confirm with trial site)
• People who have taken high-dose steroid tablets or other immune-suppressing medicines within 2 weeks before joining, with some exceptions such as steroid creams, eye drops, inhalers, or short-term use for medical procedures
• People with known active or suspected autoimmune diseases — though people with autoimmune-related underactive thyroid on thyroid replacement therapy, or type 1 diabetes managed with insulin, may potentially be considered (confirm with trial site)
• People who have received a live or live-attenuated vaccine within 4 weeks before joining
• People known to have had a severe allergic reaction to monoclonal antibodies, large protein-based medicines, or any ingredient in the trial treatment
• People with a history of immune deficiency conditions, HIV, other inherited or acquired immune system disorders, or a history of organ transplantation
• People with active hepatitis B or hepatitis C infection, or both at the same time
• People who are pregnant or breastfeeding
• People who the trial doctor considers unsuitable for any other clinical or health-related reason

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