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:

• You are willing and able to give written consent to take part and can follow the study requirements, including attending scheduled visits and treatment sessions.
• You have colorectal cancer that has spread to other parts of the body (metastatic) and is getting worse, and you have already been treated with certain standard chemotherapy and/or targeted therapy drugs (such as FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib, along with relevant antibody treatments depending on your tumour type).
• If your tumour has a specific genetic feature called MSI-high or dMMR, you must have already received immunotherapy (checkpoint inhibitor therapy) plus at least two other lines of the chemotherapy treatments listed above.
• If your tumour has a BRAF V600E mutation, you must have already received a specific combination treatment (cetuximab with encorafenib) as a second or third treatment line.
• You have at least one area of cancer that can be clearly measured on a CT or MRI scan and can be re-measured over time.
• Your general health and ability to carry out daily activities meets a certain minimum standard (called ECOG Performance Status of 2 or below — confirm with trial site if unsure what this means for you).
• You are 18 years of age or older (there is no upper age limit).
• If you are a woman who could become pregnant, or a man whose partner could become pregnant, you must agree to use two reliable forms of contraception starting from signing consent and continuing throughout treatment and for 2 months after your last dose.
• If you are a woman who could become pregnant, you must have two negative pregnancy tests before starting treatment.
• You must agree not to donate blood during the study and for 2 months after your last dose.
• Your blood tests taken within 14 days before starting treatment show that your bone marrow, kidneys, and liver are working well enough to meet specific minimum levels (confirm exact values with trial site).

Who may not be able to join:

• You have another cancer that has required treatment in the past year (with exceptions for certain types of treated skin cancer and low-grade bladder cancer).
• You have taken part in another clinical trial involving an experimental cancer treatment within the last 30 days.
• You are still experiencing significant side effects (grade 2 or higher) from previous cancer treatment, not including hair loss or nerve-related side effects.
• You currently have signs of a serious active infection.
• Your colorectal cancer has spread to the brain or the lining around the brain.
• You have a known history of HIV infection.
• You have active or chronic hepatitis B or C.
• You have an ongoing autoimmune disease (a condition where your immune system attacks your own body).
• You have a significant history of, or currently have, a serious brain or nervous system condition (such as seizures, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis — confirm with trial site if unsure whether your condition applies).
• You are currently taking blood-thinning (anticoagulation) medication.
• You have had major surgery within 4 weeks before starting the study treatment and have not yet fully recovered.
• You have received chemotherapy, certain antibody treatments, or radiotherapy too recently before starting the study (exact timeframes depend on the treatment — confirm with trial site).
• You have severe heart failure (classified as NYHA Class III or IV — confirm with trial site).
• You have a severe breathing disorder affecting how well your lungs work.
• You have a known allergy or sensitivity to the study drug (CC-3) or similar drug products, or to any of its ingredients.
• You have received a live or live-attenuated vaccine within 30 days before starting treatment.
• You are pregnant or breastfeeding.
• You currently have a bowel blockage (ileus) with severely reduced gut function.

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