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 are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with colorectal cancer (a type of cancer that starts in the colon or rectum), confirmed by a tissue or cell sample.
• People whose colorectal cancer has spread to other parts of the body (advanced or metastatic disease).
• People who are well enough to carry out light daily activities (a fitness level rated 0 or 1 on a standard medical scale, meaning fully active or able to do light work).
• For the early dose-finding part of the trial: people with colorectal cancer for whom a standard chemotherapy combination called FOLFIRI plus bevacizumab is considered appropriate, including those who have previously received a different chemotherapy called FOLFOX for advanced disease.
• For the later expansion part of the trial: people who have not previously received a chemotherapy drug called 5-fluorouracil (5FU) for metastatic disease. People who received FOLFOX or CAPOX chemotherapy before surgery or after surgery (not for metastatic disease) may be eligible if it has been at least one year since finishing that treatment with no return of cancer.
• For a small number of places (four) in the expansion part: people who have a secondary tumour that a doctor considers safe to biopsy.
• People whose blood test results at screening fall within the required ranges, including healthy enough levels of white blood cells, platelets, red blood cells, kidney function, liver function, and protein in the urine (confirm with trial site for specific values).
• People with a blood pressure reading of 160/100 mmHg or lower.
• People who have measurable signs of disease on scans, assessed within 28 days before starting the study treatment.
• People with a normal heart rhythm reading (ECG), specifically a QTcF measurement below 450 ms for men and below 460 ms for women.
• Women who are not able to become pregnant (for example, due to menopause or having had sterilisation surgery), or women who are able to become pregnant and agree to use a highly effective form of contraception during the study and for 6 months after the last dose of study treatment.
• Women who are able to become pregnant must have a negative pregnancy test at screening.
• Women who agree not to donate eggs during the study and for 6 months after the last dose of study treatment.
• Men who are sexually active with a woman who could become pregnant, and who have not had a vasectomy, must agree to use a barrier form of contraception and must not donate sperm during the study and for 3 months after the last dose of study treatment.
• People who are willing and able to understand the study, sign a consent form, and follow all study requirements for its full duration.
• People who agree not to take part in any other interventional clinical trial while receiving the study drug.

Who may not be able to join:

• People who have previously been treated with a chemotherapy combination called FOLFIRI.
• People with significant nerve damage in their hands or feet (grade 3 or higher on a standard medical scale).
• People who have untreated tumours in the brain or central nervous system, unless all known tumours in that area have been treated with radiotherapy or surgery and there has been no sign of disease returning for at least 4 weeks after treatment.
• People who have had a bone marrow or solid organ transplant from a donor.
• People with a known history of, or current, lung disease called interstitial lung disease or non-infectious pneumonitis.
• People with another cancer that could interfere with the safe assessment of this study treatment, as judged by the treating doctor.
• People with another cancer that is currently growing or requires active treatment (with some exceptions at the treating doctor's discretion).
• People who are known to have a deficiency in an enzyme called DPD, which affects how certain chemotherapy drugs are broken down by the body.
• People who are known to have a significant allergy, intolerance, or medical reason to avoid any part of the study treatment.
• People with HIV infection that is not well controlled. (People with well-controlled HIV — meaning a CD4 count above 350 and an undetectable viral load — may still be eligible.)
• People with active hepatitis B or hepatitis C infection (some exceptions apply for people with very low or undetectable levels of the virus — confirm with trial site).
• People with a serious active infection that requires intravenous antibiotics, antifungals, or antiviral medications, or any other potentially life-threatening infection.
• People who have taken part in another experimental drug study or used an experimental medical device within the past 14 days (or within 5 half-lives of that drug, whichever is longer), or who are currently in the treatment phase of another experimental study.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 150 days after the last dose; or men who plan to father a child during the study or within 150 days after the last dose.
• People who have had major surgery within 28 days before joining the study, or who have not fully recovered from major surgery within the past 14 days.
• People with other serious illnesses that, in the opinion of the study doctor, would make participation unsafe or make it difficult to properly assess the treatment.
• People with a psychiatric illness or personal circumstances (such as being incarcerated) that would make it difficult to follow the study requirements, as judged by the study doctor.
• People with a history of a hole forming in the bowel wall (perforation), an abnormal channel between organs (fistula), serious gastrointestinal bleeding, high levels of protein in the urine (more than 1 gram per 24 hours), or problems with wound healing.
• People with significant heart or blood vessel problems, including: heart failure (rated Class III or IV), a heart attack, unstable chest pain, certain heart procedures, a stroke, or a serious high blood pressure crisis within the past 6 months; a history of serious heart rhythm problems; a personal or family history of a condition called long QT syndrome; heart rhythm problems requiring medication (with some exceptions); or a blood clot in the veins or lungs within the past 6 months that has not been adequately treated.

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