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 signed a consent form and are able to follow the study requirements
• People with a laboratory-confirmed diagnosis of colorectal cancer (a specific type called adenocarcinoma) that has spread to other parts of the body, and who are being considered for first-line (initial) treatment — specific tumour genetic profiles and treatment combinations apply depending on whether the person is enrolling in Phase 1b or Phase 2 of the trial (confirm with trial site)
• People who have a stored tumour tissue sample available (preserved in a specific way called formalin-fixed, paraffin-embedded)
• People whose blood counts meet minimum levels — including haemoglobin, neutrophils (a type of white blood cell), and platelets — as confirmed by recent blood tests
• People whose liver and kidney function fall within acceptable ranges as confirmed by blood tests
• People aged 18 or older at the time of signing the consent form
• People whose cancer can be measured on imaging scans, with scans taken within 28 days before being assigned to treatment
• People with a general health and activity level rated as 0 or 1 on a standard oncology scale (meaning fully active or able to carry out light work)
• People with a life expectancy of more than 12 weeks
• Female patients who are either surgically unable to become pregnant, past menopause, or have a negative pregnancy test within 72 hours before starting treatment
• Female patients of childbearing potential who agree to use highly effective contraception during treatment and for at least 15 months after treatment ends
• Female patients who agree not to donate eggs during treatment and for at least 15 months after the last dose
• Male patients with female partners of childbearing potential who agree to use adequate contraception during treatment and for at least 12 months after treatment ends
• Male patients who agree not to donate sperm during treatment and for at least 12 months after the last dose

Who may not be able to join:

• People for whom surgery or other cancer treatments (outside of this study) have been recommended for their colorectal cancer, as confirmed by a multidisciplinary tumour board
• People who have had another cancer in the past 2 years, with some exceptions — certain treated skin cancers, carcinoma in situ (early-stage localised cancer), controlled advanced prostate cancer, or ongoing hormone therapy after breast or prostate cancer may still be eligible (confirm with trial site)
• People who have already received certain chemotherapy or targeted therapy drugs (5-FU, oxaliplatin, irinotecan, bevacizumab, cetuximab, or panitumumab) for their metastatic colorectal cancer
• People who received more than 6 cycles (approximately 3 months) of oxaliplatin as part of a previous adjuvant (preventative/post-surgery) treatment course
• People with a known history of cancer that has spread to the brain or to the lining of the brain and spinal cord
• People who have taken part in another clinical trial or received an experimental treatment within 14 days or 5 half-lives before starting this study (whichever is shorter), or who would be in another clinical trial at the same time as this one
• People who have previously received the study drug arfolitixorin
• People who have had major surgery or a serious injury within 8 weeks before starting treatment
• People with known allergic reactions to any of the study drugs or their ingredients
• People with a specific enzyme deficiency (DPD deficiency) that reduces the body's ability to safely process certain chemotherapy drugs, based on a genetic activity score below a set threshold
• People with certain heart conditions, including a recent heart attack or unstable chest pain within the past 6 months, structural heart problems, moderate-to-severe heart failure, irregular heart rhythms, a specific heart electrical abnormality (QT prolongation above 450 ms), or reduced heart pumping function (below 55%)
• People with an active infection currently being treated with intravenous antibiotics
• People with ongoing alcohol or drug abuse
• People with poorly controlled high blood pressure (above 150/100 mmHg), unless it has been brought under adequate control for at least one week before starting treatment
• People with moderate or severe nerve damage causing sensory symptoms (Grade 2 or higher peripheral neuropathy)
• People who are pregnant or breastfeeding
• People with any other medical condition or ongoing medication that the study doctor believes would put them at unacceptable risk, or any personal, social, or geographical circumstance that would make it difficult to follow the study schedule
• People whose tumour has a BRAF mutation or whose cancer is classified as mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)
• People whose doctors consider them suitable for a treatment regimen called FOLFIRINOX

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