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:

• Adults aged 18 or older at the time of signing the consent form.
• People with a confirmed diagnosis of colorectal cancer (confirmed through a tissue or cell sample).
• People whose cancer has spread locally or to other parts of the body, who have already received at least one prior systemic treatment, and for whom other available treatments have not worked, were not tolerated, or are not considered appropriate.
• People whose cancer can be measured using standard imaging guidelines (RECIST v1.1).
• People whose total combined size of measurable tumours (excluding certain lymph nodes) is less than 7 cm in total, and where no single measurable lesion is 5 cm or larger.
• People who are generally well enough to carry out light activity or desk work, as assessed by a standard performance scale (ECOG score of 0 or 1).
• People whose blood test results meet specific thresholds for white blood cells, platelets, haemoglobin, potassium, liver enzymes, bilirubin, kidney function, and blood clotting — as measured by a local laboratory (confirm specific values with the trial site).
• Women who could become pregnant must have two negative pregnancy tests before starting the study drug, and must agree to use a highly effective form of contraception from signing the consent form, throughout the study, and for 28 days after the last dose.

Who may not be able to join:

• People with a known allergy or sensitivity to the study drug NILK-2301 or any of its ingredients.
• People who have tumours affecting the brain, spinal area, or bones.
• People who have tumours affecting the lining around the lungs or the heart.
• People who have received radiotherapy to the tumour areas being studied within 4 weeks before the first dose.
• People who have received anti-cancer treatments (including chemotherapy, hormonal therapy, or experimental treatments) within 28 days before starting the study drug (low-dose steroids, localised radiotherapy to non-target areas, and certain bone-protective medicines may be exceptions — confirm with the trial site).
• People who are currently participating in another clinical trial or using another experimental treatment.
• People with severe heart failure (classified as NYHA class III or IV).
• People with significant liver problems, based on specific blood test results.
• People with a known HIV infection, or a known history or blood test evidence of hepatitis B or C infection.
• People with an active, uncontrolled infection (bacterial, viral, fungal, or other) that has not improved with treatment, or who have received intravenous antibiotics or anti-infective treatment within 2 weeks before the first dose.
• People with a confirmed history of, or currently active, autoimmune disease or any condition requiring long-term immune-suppressing treatment (low-dose steroids for conditions like rheumatoid arthritis may be an exception — confirm with the trial site).
• People who have another active cancer currently requiring ongoing systemic treatment.
• People with cancer that has spread to the brain or the membranes surrounding it, or who have a seizure disorder requiring ongoing treatment.
• People with low white blood cell counts (neutrophils below 1 x 10⁹/L), not boosted by certain growth factor injections in the 14 days before testing.
• People who are pregnant or breastfeeding.
• People with a history of psychiatric illness or substance use that may make it difficult to follow the study requirements or provide informed consent.
• People with other serious medical conditions or abnormal test results that, in the opinion of the study doctors and sponsor, would make participation too risky — including heart attack within the last 6 months, unstable chest pain or dangerous heart rhythm problems, uncontrolled diabetes, a severely weakened immune system, or major surgery within 4 weeks before starting the study drug.
• People who still have significant side effects (above a mild level) from any previous cancer treatment, except for hair loss, anaemia, or mild-to-moderate nerve-related symptoms.
• People who have received a live or live-attenuated vaccine within 28 days before signing the consent form.
• People who have previously been treated with a therapy that targets a protein called CEACAM5.
• People who have previously received a type of treatment called a T-cell bispecific antibody or CAR T-cell therapy.

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