Early 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 aged 18 or older, of any gender
• People who have been diagnosed with colorectal cancer confirmed by a tissue or cell test
• People whose colorectal cancer cannot be removed by surgery and has either spread locally or to other parts of the body
• People whose cancer is no longer responding to standard treatments, or who are unable to tolerate standard treatments — this includes chemotherapy drugs such as fluorouracil, oxaliplatin, or irinotecan, and targeted medicines that block tumour growth signals
• People who have at least one tumour that can be measured on a scan, according to standard medical guidelines
• People who are expected to live for at least 12 weeks
• People who are reasonably active and able to care for themselves, as measured by a standard medical scale (a score of 0, 1, or 2 on the ECOG scale — confirm with trial site)
• People who are able and willing to use effective contraception from the time of signing consent until 6 months after the last dose; women of childbearing age must have a negative pregnancy blood test within 7 days before the first dose
• People who are willing to sign a consent form and follow the trial plan

Who may not be able to join:

• People who had surgery to remove a tumour, completed standard chemotherapy afterward, and whose cancer came back more than 6 months later but who have not yet tried standard systemic (whole-body) therapy
• People whose tumour testing shows a specific feature called dMMR or MSI-H, and who have not yet received an immunotherapy medicine that targets PD-1 or PD-L1
• People who currently show signs of a blocked bowel, a bowel perforation (a hole in the bowel wall), or active bleeding — or who are assessed by the trial doctor as being at high risk of these complications
• People whose blood test results show certain liver or protein levels outside the acceptable range (confirm specific values with trial site)
• People with significant kidney problems, based on blood and urine test results (confirm specific values with trial site)
• People whose blood counts are too low — including low white blood cells, low platelets, or low red blood cells (confirm specific values with trial site)
• People with a blood clotting measurement (INR) above an acceptable level (confirm with trial site)
• People with known cancer that has spread to the brain
• People with uncontrolled high blood pressure, uncontrolled diabetes, or serious heart or lung conditions, or severe problems with other major organs
• People who have received cancer treatment — such as immunotherapy, targeted therapy, or chemotherapy — within the past 4 weeks, or radiotherapy within the past 3 weeks (some exceptions may apply — confirm with trial site)
• People who are still experiencing side effects from previous cancer treatments that are rated at a moderate level or above (Grade 2 or higher), not including hair loss or other effects the trial doctor considers manageable
• People with active infections that cannot be controlled, such as lung or abdominal infections
• People who have had another cancer in the past 5 years, with some exceptions for certain early-stage or very low-risk cancers (confirm with trial site)
• People who have had an active autoimmune disease requiring ongoing treatment in the past 2 years, or whose doctor believes such a disease could return — examples include lupus, inflammatory bowel disease, and certain thyroid conditions
• People who need regular steroid medicines (above a low daily dose) or other medicines that suppress the immune system, taken within 14 days before the first dose
• People who have had, or are planning to have, a transplant of an organ or bone marrow from another person
• People who test positive for hepatitis B virus DNA or hepatitis C virus RNA in their blood
• People with known active tuberculosis, or suspected active tuberculosis based on scans, sputum tests, or symptoms
• People who test positive for HIV
• People who are pregnant, breastfeeding, or cannot rule out the possibility of being pregnant
• People who have taken part in another drug trial within the past 4 weeks
• People the trial doctor considers unsuitable for any other reason

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