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:

• People who have signed and dated a consent form agreeing to take part in the study
• People who have been confirmed by laboratory testing to have metastatic colorectal adenocarcinoma (a type of bowel cancer that has spread to other parts of the body), or who are willing to have a tissue sample (biopsy) taken during screening if older test results are not available
• People whose colorectal cancer has spread to distant parts of the body either from the start or after returning, and who have not yet had treatment for the metastatic (spread) stage of their cancer
• People whose tumour has a specific genetic profile called "RAS wild-type" (meaning certain gene mutations are absent)
• People who are considered reasonably active and able to care for themselves, as assessed by a standard medical scale (ECOG score of 0 or 1)
• People who have at least one tumour that can be measured on scans according to standard criteria (note: having only a single measurable bone lesion is not sufficient)
• People whose side effects from any previous early-stage treatment (such as chemotherapy given before or after surgery) or surgical complications have largely resolved to a mild level or better, with some exceptions for lasting minor effects like hair loss
• People whose blood levels of magnesium, calcium, and potassium are at or above certain minimum levels at the time of joining the trial
• People expected to live for at least 13 weeks from the time of joining the trial, based on the treating doctor's assessment
• People of childbearing potential who agree to use highly effective contraception or remain abstinent from heterosexual intercourse from the time of signing consent, throughout treatment, and for 6 months after the last chemotherapy dose and 2 months after the last dose of the study antibody treatment
• People who the investigator believes will be able to follow all the study procedures as required
• For people taking part in a specific blood-level monitoring part of the study: people whose body weight is between 50 and 100 kg at the time of signing the consent form

Who may not be able to join:

• People who have previously received systemic (whole-body) anti-cancer drug treatment, other than early-stage fluoropyrimidine-based chemotherapy (a specific type of chemotherapy given before or after surgery)
• People who have previously been treated with anti-EGFR medicines, such as cetuximab, panitumumab, gefitinib, erlotinib, or afatinib
• People currently receiving other immunotherapy, hormone-based cancer therapy, or other cancer treatments not included in this study's plan
• People who have had major surgery within the past 28 days, or who have had radiotherapy (other than palliative radiotherapy for symptom relief) within the past 14 days with remaining side effects, before the planned start date
• People whose tumour has a BRAF gene mutation (testing will be arranged if results are not already available, and results must be known before joining)
• People with serious other illnesses or life-threatening complications of their cancer, including large build-up of fluid in the chest, heart lining, or abdomen that requires medical intervention
• People with a blocked or paralysed bowel, or uncontrolled diarrhoea that persists despite treatment
• People with brain or spinal metastases (cancer spread to the brain or spine) that are growing, causing symptoms, or requiring certain medications — though people with treated and stable brain metastases that have been stable for at least 4 weeks and require no steroids or anti-seizure medication may still be considered (confirm with trial site)
• People with certain serious heart conditions at the time of screening, including severe or unstable chest pain (angina), a heart attack within the past month, significant uncontrolled heart rhythm problems, severe heart failure, or blood pressure that remains high despite medication
• People with severe breathing difficulties, or other serious uncontrolled illness
• People with Gilbert's syndrome (a liver condition affecting how the body processes a substance called bilirubin), either currently or in their medical history
• People whose blood test results show low levels of white blood cells (neutrophils), platelets, or haemoglobin (red blood cell protein) below the specified minimum levels
• People with poor kidney function, based on blood test results falling outside acceptable ranges
• People with poor liver function, based on blood test results for bilirubin or liver enzymes falling outside acceptable ranges
• People whose cancer could potentially be completely removed by surgery
• People who have had another cancer in the past 5 years that was actively treated or is still progressing, with some exceptions for certain early-stage or skin cancers
• People with conditions that limit their ability to follow the study's requirements, such as dementia, certain neurological or psychiatric disorders, drug addiction (not including prescribed pain relief), alcohol dependence, or personal or religious beliefs that may prevent acceptance of certain standard treatments used in the study (such as blood transfusions)
• People currently participating in another clinical trial, or who participated in another clinical trial within the past 30 days (if at least one dose of the experimental treatment was received), or who have previously taken part in this specific trial and received at least one dose of the study antibody
• People who have had an active infection or a flare-up of a long-term infection within the past 28 days before the planned start date
• People who have had major surgery (involving opening the abdomen, chest, or skull under general anaesthetic) within the past 28 days — note that placement of a venous port or bowel stoma is not counted as major surgery
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis at screening or within 3 months before the planned start date
• People who are unable to receive medicines given through a vein (intravenously)
• People who cannot receive intravenous contrast dye used in certain scans
• People currently taking daily steroid medications (such as prednisolone or dexamethasone) above certain dose thresholds, not including creams or ointments applied to the skin
• People with a known allergy or intolerance to any of the study drugs or medications used alongside them
• People with a history of allergic reactions to monoclonal antibody treatments (a type of medicine made from proteins)
• People who are pregnant or breastfeeding
• People who drink more than 10 units of alcohol per week, or who have a history of alcoholism or drug addiction (one unit is approximately 250 mL of beer, 125 mL of wine, or 30 mL of spirits)
• People with any other significant health conditions or circumstances that the investigator believes could affect their safety in the study or make it difficult to interpret the results
• For people taking part in the specific blood-level monitoring part of the study: people from whom blood samples cannot be taken or who cannot have a venous catheter (small tube) inserted

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