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 cancer (a type of cancer starting in the colon or rectum) that has spread or cannot be surgically removed, and for which standard treatments are no longer working or do not exist.
• People whose cancer can be measured on scans, according to a standard set of medical measurement guidelines.
• People whose cancer has been tested and confirmed to have a specific molecular profile — specifically, proficient mismatch repair (pMMR) and/or non-MSI-H status — meaning the cancer does not have a particular genetic feature linked to a different type of treatment response (confirm with trial site for testing details).
• People in Phase 2 of the trial who have at least one area of cancer that has spread to the liver, confirmed by imaging or tissue testing.
• People in Phase 2 of the trial whose cancer has been tested and shows a specific genetic change — either a MYC amplification or a FBXW7 mutation — found through standard molecular tumour testing.
• People in Phase 2 of the trial who have at least one tumour that a doctor can safely take a small tissue sample (biopsy) from.
• People who have already been treated with, or were unable to tolerate, a standard set of chemotherapy and targeted treatments for colorectal cancer, including fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and an EGFR inhibitor (such as cetuximab or panitumumab).
• People who have completed a 28-day waiting period after stopping EGFR inhibitor treatments such as cetuximab or panitumumab.
• People aged 18 or older (no safety data is currently available for the study drugs in people under 18).
• People who are well enough to carry out basic daily activities, as assessed using a standard medical scale (ECOG performance status of 2 or better, or Karnofsky score of 60% or higher).
• People whose blood test results fall within acceptable ranges for white blood cells, platelets, haemoglobin, liver function, and kidney function, as defined by the trial.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who are on appropriate treatment and have an undetectable viral load.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who have had cancer spread to the brain that has already been treated, provided that follow-up brain scans show no sign of the cancer growing there for at least 1 month after that treatment.
• People who have had, or currently have, another type of cancer, provided that the other cancer and its treatment are unlikely to interfere with this trial's safety assessments (confirm with trial site).
• People with a history of heart problems who have been assessed and classified as Class II or better using a standard heart function scale (New York Heart Association classification).
• People who are able to use reliable contraception during the trial and for a defined period afterwards, as required by the trial protocol (see details below), and who agree not to donate eggs or sperm during this time.
• People who are able to understand the trial and are willing to sign a consent form (a legal representative may sign on someone's behalf if needed).

Who may not be able to join:

• People who have an active autoimmune disease (a condition where the immune system attacks the body) that has required systemic medical treatment in the past 2 years, such as immune-suppressing drugs or corticosteroids. Hormone replacement therapies for conditions like thyroid or adrenal insufficiency are not considered a reason for exclusion.
• People who have previously been treated with certain types of drugs — specifically RNA polymerase inhibitors, G-quadruplex stabilisers, or immunotherapy drugs including PD-1 or PD-L1 inhibitors.
• People who have a known condition that makes their skin or body abnormally sensitive to sunlight, or who are not willing to use high-SPF sunscreen (SPF 50 or above) and sunglasses when outdoors during the trial and for 4 weeks after the last dose, and to avoid tanning beds during this period.
• People who have a history of a specific type of scarring eye condition (cicatricial conjunctivitis) or who currently have an active disease affecting the surface of the eye.
• People who are still experiencing side effects from previous cancer treatments that are above a mild level (above Grade 1), except for hair loss.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have had a serious allergic reaction to drugs that are chemically or biologically similar to the study drugs (pidnarulex or cemiplimab).
• People who are currently taking strong medications that significantly affect how the body processes a particular liver enzyme (CYP3A4), as these can interfere with how the study drug pidnarulex works in the body (confirm with trial site for specific medications).
• People who are taking corticosteroids at a dose higher than 10 mg of prednisone per day, or other immune-suppressing or disease-modifying medications, as these may reduce how well the immunotherapy works.
• People who have another serious or uncontrolled medical condition that the trial team considers would make participation unsafe.
• People who are pregnant or breastfeeding, as the study drugs may be harmful to a developing baby or newborn.

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