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 been diagnosed with metastatic colorectal cancer (a type of colon or rectal cancer that has spread to other parts of the body, such as the liver or lungs), confirmed by a lab test, with a specific genetic feature called "microsatellite stable" (MSS) and any KRAS gene mutation
• People whose cancer has gotten worse after receiving certain standard chemotherapy drugs (fluoropyrimidine, oxaliplatin, or irinotecan), or who were unable to tolerate or medically could not receive those treatments
• People aged 18 or older
• People who are able to carry out normal daily activities, or have only minor limitations (this is measured by a standard medical scale called ECOG 0–1)
• People with an estimated life expectancy of at least 3 months
• People with a body mass index (BMI) of 18.5 or above
• People whose blood test results meet certain minimum levels for white blood cells, red blood cells, and platelets (confirm specific values with trial site)
• People whose liver and kidney function blood test results are within acceptable ranges (confirm specific values with trial site)
• People who have measurable cancer visible on scans, according to standard medical guidelines
• People who do not currently have, and have not previously had, another cancer that requires active treatment
• Women who could become pregnant must be willing to use highly effective contraception from the screening visit until 90 days after the last dose of the study treatment (abstinence is accepted if that is the person's established and preferred method)
• Women who could become pregnant must have a negative blood pregnancy test at screening, taken within 72 hours before the first dose
• Women who cannot become pregnant are defined as those who are 45 or older and have not had a period for more than 1 year, those who have not had a period for more than 2 years with hormone levels confirming menopause, or those who have had their uterus, ovaries, or fallopian tubes surgically removed
• Men with a female partner who could become pregnant must agree to use highly effective contraception from screening until 90 days after the last dose; men with pregnant partners must agree to use a condom (abstinence is accepted if that is the person's established and preferred method)

Who may not be able to join:

• People who currently have a diagnosis of diabetes mellitus (note: people with pre-diabetes, a past history of diabetes, or glucose intolerance who are not currently taking any diabetes medications may still be eligible — confirm with trial site)
• People who take medications that cannot be safely stopped during fasting periods, or that must be taken with food
• People who have received chemotherapy, biological therapy, radiation therapy, or had major surgery within 3 weeks before the first dose of the study drug (a shorter 1-week waiting period may be allowed for certain limited radiation treatment — confirm with trial site)
• People who have a history of fainting related to restricting food or calorie intake, or who have another medical condition that would make fasting potentially dangerous
• People who are currently taking oral vitamin C supplements
• People who are currently in another clinical trial receiving an experimental treatment, or who have received an experimental treatment within 3 weeks before the first dose of this study drug
• People who are expected to need any other cancer treatment (such as additional drug therapy, radiation, or surgery) while participating in this trial
• People who have previously received certain types of immunotherapy drugs known as anti-PD1 or anti-CTLA4 treatments
• People who have unresolved side effects of grade 2 or higher from previous treatments, with the exception of nerve damage (neuropathy) or hair loss (alopecia) (confirm grading with trial site)
• People who have untreated cancer that has spread to the brain or the lining of the brain and spinal cord, or previously treated brain metastases that have left ongoing neurological problems, a history of seizures, or a requirement for steroids above a certain dose
• People who have uncontrolled or severe imbalances in certain blood salt or mineral levels, including sodium, potassium, or magnesium (confirm specific conditions with trial site)
• People who have certain inherited or existing conditions that make their red blood cells prone to breaking down, such as G6PD deficiency or hereditary spherocytosis
• People who have a history of kidney stones made of oxalate
• People who have had major surgery within 4 weeks before the first dose of the immunotherapy component of the study
• People who have had a severe allergic reaction (grade 3 or higher) to certain types of antibody-based medicines, or who have a history of severe immune-related side effects such as serious bowel or lung inflammation, anaphylaxis, interstitial lung disease, or uncontrolled asthma
• People who have a condition that causes abnormal bleeding or significant problems with blood clotting
• People who are taking steroid medications by mouth or injection within 1 week before the first dose of the study drug (note: steroids used to prevent reactions to contrast dye, low-dose daily replacement steroids, and inhaled or topical steroids are generally permitted — confirm with trial site)
• People who have an autoimmune disease that has required systemic medical treatment within the past 2 years (note: people with autoimmune conditions managed only with hormone replacement therapy or topical treatments may still be eligible — confirm with trial site)
• People who have received an organ or tissue transplant from another person, except for corneal (eye) transplants
• People who do not have the legal capacity to make their own decisions
• People who have another serious uncontrolled illness, such as an active serious infection, uncontrolled heart failure, active coronary artery disease, a heart attack or stroke within the past 6 months, unstable chest pain, a serious heart rhythm problem, or a mental health or social situation that would make it difficult to follow the study requirements

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