This phase 3 trial will investigate the safety and effectiveness of adagloxad simolenin (AGS)/OBI-821 in triple-negative breast cancer (TNBC). The main outcome will be a change in survival without invasive disease.
Breast cancer (BC) is one of the most common cancers. BC treatment depends on the tumor type. Triple-negative breast cancer (TNBC) is a type of BC that does not express hormone receptors or the HER2 protein. TNBC does not respond to hormonal therapy. Patients with TNBC are at a higher risk of recurrent cancer. Adagloxad simolenin (AGS) is an experimental drug to treat TNBC. It attaches to a sugar molecule that tumors express called globo H. This helps the body’s immune system to detect and kill cancer cells. OBI-821 is an adjuvant drug. It improves the response of the immune system when AGS binds to the protein.
This trial will investigate the safety and effectiveness of AGS/OBI-821 in TNBC. The main outcome will be the change in survival without invasive disease.
Who are they looking for?
This trial will recruit 668 participants. Patients with invasive TNBC are eligible for the trial. Patients must have a tumor biopsy (sample) to determine a globo H score. Patients must have completed anti-cancer therapy prior to the trial and should have recovered from side effects from previous therapies. Participants must agree to use effective contraception during the trial and up to 4 weeks after and should have adequate heart, kidney, and liver function.
Patients with a previous history of BC in the other breast and those with cancer that has spread to other organs cannot take part in the trial. Previous therapy with drugs that target the immune system is not allowed. A recent history of some other cancers (up to 5 years) is also not allowed. Other exclusion criteria are autoimmune conditions, active infections, uncontrolled heart conditions or recent vaccinations.
How will it work
Patients will be assigned to one of 2 groups. Patients in the treatment group will receive AGS/OBI-821 on a weekly or fortnightly basis up to a total of 21 injections under the skin. Patients in the control group will receive placebo (inactive drug). This will last 100 weeks. The effect of treatment will be monitored for up to 7 years.
The main outcomes will be survival without invasive disease, recurrence, and overall survival. Side effects will also be monitored.