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 given written consent before any study-related procedures begin.
• People aged between 18 and 80 years old, male or female.
• People who have been diagnosed with a solid tumour confirmed by a tissue biopsy.
• People who have at least one tumour that can be measured using standard criteria (previously treated areas, such as those that received radiotherapy, do not count as measurable).
• People whose general physical functioning is rated as good or fully active on a standard oncology scale (ECOG score of 0 or 1).
• People who have been assessed as having a low nutritional risk using a standard screening tool (NRS-2002 score below 3).
• People with a Body Mass Index (BMI) of 18.5 or above (this may be adjusted based on individual circumstances).
• People who are able to eat by mouth or through a feeding tube and can tolerate nutrition given through the digestive system.
• People whose blood and organ function results meet the required levels, including acceptable counts for white blood cells, platelets, and red blood cells; adequate liver, kidney, and blood-clotting function; and low levels of protein in the urine — as determined by blood and urine tests carried out by the trial site.
• Women who could become pregnant must agree to avoid pregnancy from the time of signing consent until at least 6 months after the last dose of the study drug, must have a negative pregnancy blood test within 3 days before starting treatment, and must not be breastfeeding.
• All participants where there is any risk of pregnancy must use a highly effective form of contraception throughout treatment and for 120 days (or 180 days if chemotherapy is involved) after the last dose of the study drug.

Who may not be able to join:

• People with a cognitive impairment or mental illness that would prevent them from understanding the study.
• People whose cancer has spread to the brain or the membranes surrounding the brain or spinal cord.
• People who have a moderate or severe build-up of fluid in the abdomen that required drainage in the two weeks before starting the study (people with only a small amount of fluid on scans and no symptoms may still be considered).
• People with uncontrolled or significant build-up of fluid around the lungs or heart.
• People with serious digestive problems, such as severe diarrhoea, uncontrollable vomiting, severe inability to absorb nutrients, bowel obstruction, abnormal connections or holes in the digestive tract, abdominal abscess, or certain types of significant bleeding within the past 3 to 6 months (confirm with trial site).
• People who are known to be allergic to any ingredient in the study drug.
• People with poorly controlled diabetes.
• People whose blood pressure remains too high despite taking blood pressure medication (systolic at or above 140 mmHg and/or diastolic at or above 90 mmHg), or who have a history of a severe hypertensive crisis or hypertension-related brain complications.
• People who have had a stroke, mini-stroke (TIA), heart attack, or major blood vessel disease within the 6 months before joining, or who have poorly controlled heart conditions such as unstable chest pain, moderate-to-severe heart failure, significantly reduced heart pumping function, or serious irregular heart rhythms that cannot be controlled with medication.
• Women who are pregnant or breastfeeding.
• People whom the trial investigators consider unsuitable for participation for any other reason.

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