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:

• You carry a genetic change (variant) in one of the following DNA repair genes: MLH1, MSH2, or MSH6, which is known or likely to increase cancer risk.
• You have no current or past history of invasive cancer.
• Your colon can be reached and examined using a standard camera procedure (colonoscopy).
• You are willing to have regular colonoscopies with tissue samples taken every 1–2 years as part of standard monitoring.
• You are 18 years of age or older.
• You are generally able to carry out daily activities with little or no limitation (confirm with trial site).
• Your blood counts and blood cell levels meet certain minimum thresholds, as checked by a blood test (confirm with trial site).
• Your kidneys are working well enough, as shown by a blood or urine test (confirm with trial site).
• Your liver enzyme levels are within an acceptable range, as shown by a blood test (confirm with trial site).
• Your liver's bilirubin levels are within an acceptable range; people with a condition called Gilbert's disease may still be eligible under slightly different values (confirm with trial site).
• You are willing and able to give written consent to take part.
• If you are a woman who could become pregnant, you must have a negative pregnancy test before joining and agree to use reliable contraception until one year after your last study treatment dose.

Who may not be able to join:

• You carry a genetic change in a gene called PMS2.
• You have or have had cancer in the past (skin cancers other than melanoma are generally not excluded).
• You take daily aspirin at doses over 100 mg, or regularly take anti-inflammatory painkillers (such as ibuprofen), and cannot stop these for the duration of the trial.
• You have a serious, unstable medical condition, mental health condition, or other problem that could affect your safety or ability to take part.
• You currently have an active bacterial, viral, or fungal infection, or you have HIV or test positive for HIV.
• You test positive for Hepatitis B or Hepatitis C at screening.
• You have previously had an organ transplant or have a known condition that weakens your immune system.
• You need to take steroid medicines or other drugs that suppress the immune system on an ongoing basis.
• You are pregnant, breastfeeding, or planning to become pregnant within the first year after completing the study treatment.
• You are a man planning to try to father a child within the first year after completing the study treatment.
• You have taken part in another clinical trial in the month before joining this one.
• You are unable to avoid receiving any type of vaccine during the first 12 weeks of the trial.
• A procedure to collect white blood cells from your blood (called leukapheresis) is not possible for you — for example, because suitable veins cannot be accessed.
• Any other issue that the trial doctor believes could interfere with the study (confirm with trial site).

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