Phase 2 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 colorectal (colon or rectal) cancer, confirmed by a tissue or pathology test.
• People who have completed all planned treatments aimed at curing their cancer (such as surgery to remove all visible cancer) and currently show no signs of the disease on scans or other standard assessments, at least 28 days after finishing treatment.
• People whose scans show no measurable or detectable cancer at least 28 days after completing all standard treatments.
• People who have had a specific blood test called Signatera (a ctDNA test) come back positive at least 28 days after finishing all standard treatments — results from tests done at other hospitals are accepted.
• People whose blood counts and organ function (including white blood cells, platelets, haemoglobin, liver values, and kidney function) meet the required levels as determined by blood tests.
• People who are generally well enough to carry out daily activities, rated as fully active or restricted only in physically strenuous activity (ECOG performance score of 0 or 1).
• People aged 18 or older at the time of signing the consent form.
• People who are able to understand and willing to sign a written consent form agreeing to take part.
• People of childbearing potential (including females from the onset of menstruation, as early as age 8, up to age 55) and their partners who agree to use an approved form of contraception before, during, and for at least 90 days after the last dose of the study treatment — unless they meet specific exemption criteria such as being postmenopausal, having had a hysterectomy, bilateral removal of ovaries or fallopian tubes, confirmed ovarian failure following pelvic radiation, or having had a surgical sterilisation procedure.
• Approved contraception methods include hormonal contraception (pill, injection, implant, patch, or vaginal ring), intrauterine device (IUD), tubal ligation, hysterectomy, vasectomy of the partner, implantable or injectable contraceptives, or condoms used with spermicide. Completely refraining from sexual activity for the full duration of the trial and washout period is also acceptable. Note: periodic abstinence, the rhythm method, and the withdrawal method are not considered acceptable.
• Men enrolled in the trial must also agree to use adequate contraception before, during, and for 90 days after completing the study treatment.

Who may not be able to join:

• People who have had another cancer diagnosis within the past 3 years that could interfere with assessing the safety or effectiveness of the study treatment, or that requires ongoing treatment (confirm with trial site for examples such as certain skin cancers or early-stage cancers in situ).
• People with significant liver or bile duct disease that the treating doctor considers too risky for participation.
• People with a chronic hepatitis B virus (HBV) infection where the virus is still detectable in the blood (those on suppressive therapy with undetectable levels may still be considered — confirm with trial site).
• People with a history of hepatitis C virus (HCV) infection who have not been successfully treated and cured, or who are currently being treated but still have detectable levels of the virus in their blood.
• People with other significant ongoing health conditions, including certain autoimmune or heart-related conditions, that the treating doctor considers too significant for safe participation.
• People still experiencing side effects from previous cancer treatment that are rated moderate or worse (grade 2 or above), except for hair loss or nerve-related side effects.
• People with another existing illness, metabolic condition, abnormal test result, or other condition that may prevent safe use of the study drug or put them at unreasonable risk of harm.
• People who have previously had a severe allergic reaction (grade 3 or 4) to a humanised or human monoclonal antibody therapy.
• People who are pregnant, as the study drug may harm a developing baby. People who are breastfeeding would need to stop breastfeeding if enrolled, due to unknown risks to the infant.
• People currently receiving other cancer treatments, such as chemotherapy, hormone therapy, immunotherapy, or other investigational treatments not part of this trial.
• People who have used certain targeted cancer drugs — specifically pexidartinib, other oral tyrosine kinase inhibitors (such as imatinib or nilotinib), or any treatment targeting CSF1 or CSF1R — within the past 4 weeks.
• People with psychiatric conditions or personal circumstances that would make it difficult to follow the trial requirements.

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