Phase 1 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:

• Adults between 18 and 70 years of age
• People who have been diagnosed with advanced colorectal cancer, confirmed by both laboratory tissue testing and imaging scans, with at least one tumour that can be measured on a scan
• People whose cancer has not responded to standard treatments, who are not suitable for standard treatments, or who have chosen not to receive standard treatments
• People whose doctors expect them to live for at least 6 months
• People who are generally well enough to carry out light activity and care for themselves (a medical fitness score of 0 or 1 on a standard scale used by doctors)
• People who have enough tumour tissue available for detailed genetic analysis, or who already have qualifying genetic test results from their tumour and healthy tissue
• People whose heart, liver, and kidneys are functioning normally
• People with healthy blood counts — specifically, adequate levels of infection-fighting cells, red blood cells, and platelets
• People whose blood test results for liver and kidney function fall within acceptable ranges (slightly higher limits may apply for those with liver spread of cancer — confirm with trial site)
• Women of childbearing age who have a negative pregnancy test within 7 days before joining, do not plan to become pregnant during the study, and are willing to use effective contraception throughout
• Men who are willing to use appropriate contraception during the study
• People who are able and willing to follow the study procedures and attend all required follow-up appointments

Who may not be able to join:

• People who are unwilling to sign the consent form agreeing to take part
• People who currently have, or have recently had, another type of cancer — exceptions may apply for certain cancers that have been fully treated and have not returned for more than 5 years, such as basal cell skin cancer, thyroid cancer, or cervical dysplasia (confirm with trial site)
• People whose tumour genetic analysis does not identify suitable targets for the personalised immunotherapy used in this trial
• People who have previously had a bone marrow transplant, an organ transplant from another person, or a stem cell transplant from another person
• People who are currently taking other cancer treatments, experimental therapies, or medicines that suppress the immune system, or who take steroid medicines (such as corticosteroids) long-term
• People with brain or central nervous system cancer spread that is causing symptoms or has not been treated — people with brain metastases that have been fully removed or treated with radiation and have been stable for at least 4 weeks, with no brain swelling and no need for steroids or seizure medicines, may still be considered (confirm with trial site)
• People who have received any vaccine (other than a COVID-19 vaccine) within 4 weeks before starting treatment
• People with a confirmed active bacterial or fungal infection, or active tuberculosis, or a past history of tuberculosis
• People with active hepatitis B, hepatitis C, HIV, or syphilis infections, based on blood test results
• People with severe asthma, autoimmune conditions, or immune system disorders that require immune-suppressing treatment — some milder conditions such as vitiligo, type 1 diabetes, thyroid conditions controlled by medication, or mild psoriasis may not apply (confirm with trial site)
• People with a known history of a primary immune deficiency condition
• People with a history of a psychiatric disorder
• People with serious uncontrolled health conditions, such as active serious infections, heart failure, unstable chest pain, irregular heart rhythms, severe heart or blood vessel disease, or other conditions the doctor considers too risky
• People with substance misuse issues, or other personal, psychological, or social circumstances that may affect their ability to give informed consent or follow the study
• People with a known history of severe allergic reactions to food, medicines, or vaccines, or others considered at risk of a serious reaction to immunotherapy by their doctor
• People the trial doctor considers unsuitable for any other reason, or unlikely to complete the study

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