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 colorectal cancer (cancer of the colon or rectum) that cannot be removed by surgery, confirmed by a tissue test to be a specific type called adenocarcinoma.
• People whose cancer has been tested and confirmed to be a type called non-MSI-H or pMMR (a specific genetic characteristic of the tumour — confirm with trial site if unsure what this means for your situation).
• People whose cancer can be measured on scans using a standard measurement method called RECIST v1.1.
• People who are able to provide a tumour tissue sample (collected before the trial starts); a recent sample is preferred, but an older stored sample (less than 2 years old) may be accepted if a new one cannot be obtained.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People with a life expectancy of at least 12 weeks.
• People whose organs (such as liver and kidneys) and bone marrow are functioning adequately, based on tests done within 7 days before the trial starts.
• People who have waited an appropriate amount of time after their last treatment before joining the trial, as defined by the trial protocol.
• Depending on which group within the trial a person is being considered for, additional criteria may apply — such as having had at least 2 prior treatments for metastatic disease, having progressed after first-line chemotherapy, or not having received any prior treatment for metastatic disease (confirm specific group criteria with the trial site).

Who may not be able to join:

• People whose cancer is confirmed to be the MSI-H or mismatch repair deficient type.
• People who have previously been treated with therapies targeting specific proteins called epithelial cell-adhesion molecule or 4-1BB, or who have received immunotherapy.
• People who have previously received immune checkpoint inhibitor treatments or a specific type of combination antibody therapy targeting PD-(L)1 and a blood vessel growth factor.
• People whose cancer may be suitable for a localised treatment (such as surgery, targeted radiation, or tumour ablation) that could potentially result in a complete or near-complete response, as assessed by the treating doctor.
• People with serious, uncontrolled heart or blood vessel disease, as defined by the trial protocol.
• People whose heart pumping function (left ventricular ejection fraction) is below 50%, based on a heart scan done within 28 days before joining.
• People who have uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart that has required draining or similar procedures within the 2 weeks before joining.
• People who have active, symptomatic cancer that has spread to the brain and is untreated or requires ongoing medication to control symptoms; some people with treated, stable brain metastases may still be considered (confirm with trial site).
• People who still have side effects from previous cancer treatments that have not resolved to a mild level (with some exceptions allowed — confirm with trial site).
• People in certain trial groups who have had unusual or severe reactions to specific prior cancer treatments, or who have a known deficiency of an enzyme called DPD (which affects how certain chemotherapy drugs are processed by the body).
• People who have had another cancer diagnosis within the past 2 years, with some exceptions for certain treated or low-risk cancers (confirm with trial site).
• People who have been hospitalised for a small bowel obstruction within the 3 months before starting the trial.
• People with high levels of protein in their urine over a 24-hour period (1 gram or more).
• People with active or historical autoimmune diseases (such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions) that could be worsened by the type of treatment used in this trial, or people who have had an organ transplant or stem cell transplant; some exceptions may apply (confirm with trial site).
• People with serious wounds, ulcers, or bone fractures that have not healed, or a history of certain serious abdominal complications (such as perforation or fistula) within the past 6 months.
• People with significant blood clotting disorders or other conditions that may raise the risk of serious bleeding, as defined by the trial protocol.

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