This phase 1b trial is examining the effectiveness and safety of a vaccine treatment, ATP128, in the treatment of advanced colorectal cancer. The main outcome to be measured is the tumor response to the treatment and treatment toxicity. This trial is being conducted in Arizona and California, US.
Colorectal cancer is the third most common cancer worldwide. A significant number of patients present with metastatic (spread to other parts of the body) disease at diagnostics. In advanced cases, this therapy has only a limited effectiveness. Adding immunotherapy drugs to the treatment improves the anti-tumor effect.
Immunotherapy drugs such as ATP128 combined with BI754091 activates the immune system to start attacking and killing cancer cells. However, the effectiveness and toxicity of this therapy are not well known.
This phase 1b trial is examining the effectiveness and safety of an immunotherapy treatment, ATP128, in the treatment of advanced colorectal cancer. The main outcome to be measured is the tumor response to the treatment and treatment toxicity.
Who are they looking for?
This trial is recruiting 32 patients with advanced colorectal cancer who received first-line chemotherapy. Patients must have at least one tumor in the liver. All toxicities related to past treatment must be resolved. Participants must have a life expectancy of more than 3 months and adequate kidney, bone marrow, and liver function tests. Patients must agree to use effective birth control during the study and up to 180 days after the last dose.
Participants must not have bowel obstruction, another cancer, immune diseases, skin disease, active infection, HIV, hepatitis, brain, heart or lung disease. Patients must not have had immunotherapy within 4 weeks prior to this trial, chemotherapy within 15 days, radiotherapy within 2 weeks or major surgery within 12 weeks. Patients must not have had prior vaccination against colorectal cancer or any immunosuppressive drugs. Must not have an allergy to the drugs in the trial and must not be pregnant or breastfeeding.
How will it work
Patients eligible for this study will be assigned one of three treatments depending on certain differences of their condition. Patients will receive either ATP128 alone, ATP128 in combination with BI 754091, or ATP128 in combination with BI 754091 before and after liver surgery.
The main outcomes to be measured will be the anti-tumor effect and toxicity. The follow-up period will be 1 year.