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 been diagnosed with primary rectal cancer that has not spread to other parts of the body, confirmed through a tissue sample, and falls within a specific stage range (confirm with trial site for exact staging details)
• People whose rectal cancer has been tested and found to have a normal DNA repair system (called "proficient mismatch repair" or pMMR)
• People whose cancer is considered potentially removable through surgery with the aim of a cure
• People who have no medical reasons that would prevent them from receiving the study drug pembrolizumab
• People who do not need pre-surgery treatment (such as chemotherapy or radiation) before joining the trial
• People who are older than 18 years at the time of joining
• People who are generally well enough to carry out daily activities with little or no limitation (rated 0 or 1 on a standard health scale used by doctors)
• People whose recent blood test results meet specific levels for white blood cells, platelets, red blood cells, kidney function, liver function, and certain liver enzymes (confirm with trial site for exact values)
• People who are able to understand the trial, its potential risks and benefits, and are willing to sign a consent form

Who may not be able to join:

• People who have a bowel blockage or another condition requiring urgent surgery
• People who have received immunotherapy treatment in the 3 months before starting the trial
• People who have an active hepatitis B or hepatitis C infection
• People who have a condition that weakens the immune system, including HIV, regular use of steroid tablets above a certain dose, or other signs of a suppressed immune system
• People who have an autoimmune disease (conditions where the immune system attacks the body), with the exception of thyroid conditions managed with replacement medication and type 1 diabetes
• People who are currently taking steroid tablets or other immune-suppressing medicines above a certain dose within 14 days before receiving the study drug (inhaled or skin-applied steroids at low doses may be permitted — confirm with trial site)
• People who are currently taking certain antiviral medicines (such as ribavirin, cidofovir, or interferon) that act against a specific type of virus used in the trial
• People who have a history of severe skin conditions such as eczema or atopic dermatitis that required systemic (whole-body) treatment for more than 4 weeks in the past 2 years
• People who have received a live virus vaccine within 28 days before receiving the study drug
• People who have a known allergy to eggs or to any ingredient in the study drug BT-001
• People who are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose of the study drug
• People who are able to have children but are unwilling to use highly effective contraception during the trial and for 4 months after the last dose of treatment

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