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:

• People who have given written consent to participate (or whose legal representative has done so on their behalf)
• People who are willing to take part in all related study procedures, including brain scans (fMRI), tissue samples from the tumour and normal rectum, blood draws, and stool collection
• People aged 18 or older
• People who are reasonably active and able to care for themselves — rated 0, 1, or 2 on a standard scale used to measure how cancer affects daily functioning (confirm with trial site)
• People who have been diagnosed with rectal cancer (a specific type called adenocarcinoma) confirmed by a laboratory test
• People who, after completing a full course of pre-surgery treatment (called total neoadjuvant therapy), wish to avoid surgery and instead pursue a non-surgical approach to managing their cancer
• People whose rectal cancer is locally advanced, meaning it has grown into surrounding tissue or spread to nearby lymph nodes, but has not spread to distant parts of the body
• People whose tumour has a specific genetic characteristic called microsatellite stable (MSS) — meaning it does not have a feature called MSI-H or mismatch repair deficiency (confirm with trial site)
• People with recent blood test results (within 30 days of starting) showing white blood cell levels, platelet counts, and haemoglobin levels within acceptable ranges (confirm specific values with trial site)
• People with recent liver function test results within acceptable ranges (within 30 days of starting)
• People with adequate kidney function confirmed by a recent test (within 30 days of starting)
• People with known HIV, hepatitis B, or hepatitis C who have an undetectable viral load on recent testing — including those on effective HIV treatment with undetectable viral load within the past 6 months
• Women who could potentially become pregnant must have a negative pregnancy test result (within 30 days of starting)
• People of childbearing potential who agree to use effective contraception or abstain from heterosexual activity throughout the study and for at least 4 months after the last dose of treatment

Who may not be able to join:

• People who have received chemotherapy, biological therapy, or immunotherapy within 14 days (or within five half-lives of the drug, whichever is shorter) before the trial starts
• People who have previously had radiation therapy to the pelvis in a way that would overlap with the radiation fields used in this trial
• People who have used a medication called levodopa in the last 30 days
• People with a history of allergic reactions to drugs that are chemically or biologically similar to the study drug
• People who are unable to undergo MRI scans or internal camera (endoscopic) procedures
• People with a history of complete heart block (a specific heart rhythm problem), serious liver disease such as cirrhosis, or a condition called priapism
• People with another active cancer, unless that cancer or its treatment is unlikely to interfere with the safety or assessment of this trial (confirm with trial site)
• Women who are pregnant or breastfeeding
• People with any other health condition that the trial doctor believes would make participation unsafe
• People who, in the trial doctor's judgement, may not be able to follow all study procedures or requirements

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