Phase 1 Colorectal Cancer Trial, Recruiting

Written by an AI model from the 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 been confirmed through laboratory testing to have colorectal cancer (specifically adenocarcinoma) that has spread or cannot be surgically removed, with disease that can be measured on scans.
• People whose scans confirming measurable disease were done within 28 days before registering for the trial.
• People joining the expansion part of the trial must have tumours in a location where a research biopsy can be safely performed.
• People aged 18 or older (the trial does not include children, as safety data for this age group is not yet available).
• People who are well enough to carry out basic daily activities, as measured by standard performance scales (ECOG score of 2 or less, or Karnofsky score of 60% or higher).
• People whose recent blood test results (within 28 days of registration) show adequate levels of white blood cells, platelets, and kidney and liver function within the ranges required by the trial.
• People whose muscle enzyme levels (CPK) on recent blood tests are within an acceptable range (below a certain threshold).
• People taking cholesterol-lowering statin medication, provided the dose has been stable for at least 3 weeks before starting the study.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the last 6 months.
• People with chronic hepatitis B who are on suppressive therapy and have an undetectable viral load.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load.
• People who have previously had treatment for brain metastases (cancer that has spread to the brain), provided follow-up brain imaging shows no signs of the cancer growing.
• People with new or growing brain metastases or cancer spread to the lining of the brain or spinal cord may be considered, after discussion with the lead investigator, if the treating doctor determines that urgent brain-specific treatment is not needed during the first treatment cycle (confirm with trial site).
• People who have had or currently have another type of cancer, provided that cancer or its treatment is not expected to interfere with the safety or results of this trial.
• People with a history of heart disease or past treatment with heart-affecting medications, provided a clinical assessment places their heart function at Class II or better using standard heart function classification.
• People who are able to swallow and take oral (by mouth) medications.
• People who are able to understand the study and are willing to sign a written consent form, or who have a legally authorised representative who can do this on their behalf.
• People who agree to use adequate contraception (hormonal or barrier methods, or abstinence) before and throughout their time on the trial. Women of childbearing potential must continue contraception for 9 months after the last dose. Men must use contraception for 6 months after the last dose.

Who may not be able to join:

• People whose colorectal cancer has a specific genetic feature called MSI-H (high microsatellite instability) or dMMR (deficient DNA mismatch repair), identified before enrolment.
• People with a prolonged heart rhythm interval (QTcF greater than 450ms) on a heart tracing (ECG) done at screening.
• People who have not recovered from side effects of previous cancer treatment, where side effects are still at a significant level (above Grade 1), except for hair loss.
• People who are currently participating in another clinical trial involving an experimental treatment.
• People who have previously received any chemotherapy for colorectal cancer — including common regimens such as FOLFOX, FOLFIRI, or FOLFOXIRI — or anti-blood vessel growth treatments such as bevacizumab, whether given for early-stage or advanced disease.
• People with a known deficiency of a specific enzyme called dihydropyrimidine dehydrogenase (DPD), which affects how the body processes certain chemotherapy drugs.
• People who have had a serious allergic reaction to drugs that are chemically similar to the study drugs being used in this trial.
• People with a stomach or bowel condition that could prevent them from properly absorbing or swallowing the oral study drug.
• People with a serious uncontrolled illness or any other significant health condition that would make participation unsafe.
• People who are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days before starting the study.
• People who have had an organ transplant or stem cell transplant from a donor.
• People with significant active bleeding, or for whom the treating doctor considers bevacizumab to be unsafe or inappropriate.
• People who have received radiation therapy to bone metastases within 2 weeks before the planned start of treatment.
• People who have had a major surgical procedure within 4 weeks before the planned start of treatment.
• People with high blood pressure that is not adequately controlled with blood pressure medication.
• People who have taken systemic (whole-body) immune-suppressing medications within 14 days before joining the trial — though some exceptions apply for low-dose or short-term steroid use, inhaled steroids, or certain steroid treatments for specific conditions (confirm with trial site).
• People who have had a serious infection within 28 days before registration, including hospitalisation for infection, bacteria in the bloodstream, or severe pneumonia, or who have taken oral or intravenous antibiotics within 14 days before registration (people on preventive antibiotics for ongoing conditions may still be eligible — confirm with trial site).

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