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:

• Adults between 18 and 75 years old (inclusive), of any gender
• People diagnosed with a specific type of colorectal or rectal cancer (adenocarcinoma) confirmed by laboratory testing, classified as stage IV, and identified as a particular molecular subtype called MSS or pMMR — a local lab report confirming this must be provided
• People who have not previously received any systemic (whole-body) treatment for their advanced cancer; or, if they did receive treatment before or after surgery in an earlier stage, their cancer must not have come back or gotten worse until more than 12 months after that treatment ended
• People with a general health performance score of 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity) (confirm with trial site)
• People whose life expectancy is estimated to be at least 12 weeks
• People who have at least one tumour that can be measured on a scan, according to standard criteria
• People whose liver, kidneys, heart, and other organs are functioning well enough to meet the trial's requirements (confirm with trial site for specific values)
• People who are able to have children must agree to use effective contraception during the study and for 6 months after the last dose, and must not be planning a pregnancy during this time; women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose and must not be breastfeeding
• People who are willing to take part voluntarily, have given their full informed consent in writing, and are able to follow the study requirements

Who may not be able to join:

• People who have previously been treated with a type of immunotherapy drug called a PD-1 or PD-L1 inhibitor; or, for one specific group in the trial, people who have previously received a DKK1 inhibitor treatment
• People who have had major surgery or radiotherapy within 28 days before the first dose (palliative radiotherapy for bone or brain lesions is allowed if completed at least 14 days before); had a needle biopsy or minor procedure within 7 days before starting the study (except for placement of a vascular access device); used high-dose blood-thinning or anti-clotting medications within 14 days before the first dose; used corticosteroids at a dose higher than 10 mg prednisone per day (or equivalent) for more than one week before the first dose (low-dose or inhaled/topical steroids may be allowed — confirm with trial site); or received a live or weakened live vaccine within 28 days before the first dose, or are expected to receive one during the study (for combination therapy participants)
• People whose side effects from previous cancer treatment have not returned to an acceptable level, unless the trial team and sponsor have reviewed the situation and agreed the person may still be considered (confirm with trial site)
• People who have had a digestive tract perforation, a hole or passage between organs (fistula), an abdominal abscess, or an ulcer disease of the digestive system in the 6 months before the first dose (a stable ulcer condition may be considered by the investigating doctor)
• People who have fluid build-up around the lungs, abdomen, or heart that is causing symptoms and requires repeated draining or other procedures
• People with a history of a lung condition called interstitial lung disease, or a history of non-infectious lung inflammation that was treated with steroids, or signs of active lung inflammation seen on a scan at screening
• People with serious wounds that have not healed, open wounds, active ulcers, or untreated broken bones (old fractures not needing medical treatment may be acceptable — confirm with trial site)
• People with signs of a significant bleeding tendency or a serious blood-clotting problem; a history of gastrointestinal (gut) bleeding in the 6 months before joining; a clear risk of gut bleeding (such as severe varicose veins in the oesophagus or stomach, active ulcers, or persistent blood detected in stool tests); significant coughing up of blood or tumour-related bleeding in the 28 days before the first dose; or scan results suggesting the tumour is near major blood vessels or has areas of breakdown that the investigating doctor believes pose a bleeding risk
• People with poorly controlled high blood pressure (systolic at or above 150 mmHg and/or diastolic above 100 mmHg), or a history of a hypertensive crisis or hypertensive encephalopathy (a serious complication of very high blood pressure)
• People with serious heart or blood vessel conditions, including but not limited to: previous heart attack, severe or unstable chest pain (angina), heart failure of a certain level of severity, significant irregular heartbeats requiring medication, aortic aneurysm needing surgery, any arterial blood clot or blockage, serious venous blood clots, mini-strokes or strokes, a heart pumping function below 50% on ultrasound, or an abnormal heart rhythm measurement (QTc above 480 ms)
• People with active cancer spread to the brain or the lining around the brain; people with spread to the brainstem are not eligible regardless of prior treatment; people who have had prior brain radiotherapy or surgery may be considered if scans within 4 weeks show stable disease, no worsening neurological symptoms, and steroid treatment was stopped at least 2 weeks before the first dose (confirm with trial site)
• People who had a serious infection (such as severe pneumonia or a bloodstream infection requiring hospitalisation) within 28 days before the first dose; or an active infection requiring treatment, or an unexplained fever above 38.5°C, within 2 weeks before the first dose (fevers caused by the tumour itself may be assessed differently by the investigating doctor)
• People with active tuberculosis, active hepatitis B (with certain virus levels above a set threshold), or active hepatitis C (with detectable virus levels)
• People with a history of immune system deficiency diseases, a positive HIV test, or a history of receiving a transplanted organ or bone marrow/stem cells from another person
• People who have had an active autoimmune disease requiring systemic treatment (such as steroids or immune-suppressing drugs) within the 2 years before the first dose — examples include lupus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, and vasculitis; some conditions such as well-controlled thyroid or hormonal conditions, type 1 diabetes, psoriasis or vitiligo not requiring systemic treatment, and childhood asthma that has resolved may still be eligible (confirm with trial site)
• People who have had another type of cancer, unless it was treated with curative intent, there has been no known active disease for more than 5 years, and the risk of it returning is considered low; certain skin cancers that have been treated may also be acceptable (confirm with trial site)
• People with other serious physical or mental health conditions, or significant abnormal laboratory results, that the investigating doctor believes would make participation unsafe, affect the ability to follow the study plan, or interfere with the study results

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