Balstilimab + Botensilimab + agenT-797 for Colorectal Cancer

This trial tests a combination of three treatments—balstilimab, botensilimab, and agenT-797 (experimental treatment)—to determine if they can shrink tumors in individuals with metastatic colorectal cancer that has spread to the liver. Participants have previously tried other treatments, but those were insufficient. The study also examines potential side effects of this new approach. Individuals with colorectal cancer that has spread to the liver and have a tumor type known as microsatellite stable may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

The trial protocol does not specify if you need to stop taking your current medications. However, there are specific 'washout' periods (time without taking certain medications) for prior anti-cancer therapies, so it's best to discuss your current medications with the trial team.

Research has shown that the combination of balstilimab, botensilimab, and agenT-797 has been tested in about 1,100 patients and appears safe. Importantly, in a study focusing on agenT-797, none of the 82 participants experienced a severe immune reaction known as cytokine release syndrome. Another study found that treatment-related side effects were common, with 35% of patients experiencing fatigue and 32% experiencing diarrhea. Although these side effects occurred frequently, they were generally easy to manage. This suggests that the treatment is generally well-tolerated.¹²³⁴⁵

Researchers are excited about the combination of balstilimab, botensilimab, and agenT-797 for colorectal cancer because these treatments offer a fresh approach compared to current options like chemotherapy and targeted therapies. Unlike traditional treatments, balstilimab and botensilimab are immune checkpoint inhibitors that work by unleashing the body's immune system to better recognize and attack cancer cells. AgenT-797, on the other hand, is a unique allogeneic cell therapy that helps enhance the immune response. This combination has the potential to offer a more targeted and effective attack on cancer cells, possibly leading to better outcomes for patients.

Research has shown that combining balstilimab and botensilimab may help treat colorectal cancer, particularly in patients with microsatellite stable (MSS) cancer. One study demonstrated a 42% survival rate over two years, with patients living an average of 20.9 months. Early trials with agenT-797 showed it to be safe and potentially effective in enhancing the body's immune response against cancer. In this trial, participants will receive a combination of balstilimab, botensilimab, and agenT-797 to strengthen the immune system's ability to fight cancer cells. This combination therapy offers a new option for patients whose cancer has spread to the liver and who have already received other treatments.¹²⁵⁶⁷