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 sign a written consent form agreeing to take part in the study.
• People aged between 18 and 75 years old (any gender).
• People whose general physical fitness is rated as 0 or 1 on a standard cancer performance scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
• People whose doctors expect them to live for at least 3 months.
• People who have been diagnosed with colorectal cancer that has spread to other parts of the body (metastatic colorectal adenocarcinoma), confirmed through tissue or cell testing.
• People with colorectal cancer who have not yet received any systemic anti-cancer treatment, and for whom surgery or local treatments aimed at curing the cancer are not considered suitable options.
• People whose genetic test results show specific tumour markers known as pMMR or MSS, and who also have a RAS gene mutation.
• People who have at least one tumour that can be clearly measured and tracked over time using standard imaging guidelines (brain tumours cannot be used as the main measuring target).

Who may not be able to join:

• People whose tumour genetic testing shows MSI-H or dMMR results.
• People whose tumour testing shows a RAS wild-type result (meaning no RAS mutation is present).
• People who have had another type of cancer within the past 3 years, unless it was a localised cancer that has been fully treated and cured (such as certain skin cancers, early-stage bladder cancer, or cervical carcinoma in situ).
• People who are currently taking part in another clinical trial that involves an active treatment or intervention (observational studies or follow-up phases may be acceptable — confirm with trial site).
• People who have received certain anti-cancer or immune-related treatments within specific timeframes before joining, including chemotherapy within the past 3 weeks, local palliative treatment within the past 2 weeks, certain immune-boosting therapies within the past 2 weeks, or herbal/traditional medicine with anti-cancer indications within the past week.
• People who have previously received any form of immunotherapy for cancer, including checkpoint inhibitors, immune agonist therapies, immune cell therapies, or any other treatment targeting the immune system's response to cancer.
• People who have an active autoimmune disease that has required ongoing medical treatment within the past two years (note: hormone replacement therapies for conditions such as thyroid or adrenal disorders are not considered disqualifying — confirm with trial site).
• People with a history of inflammatory bowel conditions such as Crohn's disease, ulcerative colitis, or chronic diarrhoea.
• People with a history of immune system deficiency, a positive HIV test, or who are currently taking long-term steroids or other immune-suppressing medications.
• People with known active tuberculosis (TB), suspected active TB that has not been ruled out by medical examination, or known active syphilis infection.
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from another person.
• People who have had, or currently have, a non-infectious lung inflammation or scarring condition (such as interstitial lung disease) that has required treatment with steroid medication.

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