Phase 1b Study of Botensilimab and Balstilimab with Fasting-Mimicking Diet and Vitamin C for Adults with KRAS-Mutant Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the safety, side effects, and potential effectiveness of combining botensilimab and balstilimab with a fasting mimicking diet and high dose vitamin C in patients with KRAS-mutant metastatic colorectal cancer. This phase Ib trial aims to study how this combination may impact tumor growth and spread, focusing on patients whose cancer cells have a specific KRAS mutation that might respond differently to vitamin C and dietary changes. Patients receive botensilimab intravenously over 30 minutes on day 1 of each 42-day cycle for up to four cycles. Balstilimab and vitamin C are given intravenously on days 1, 15, and 29 of each cycle. Participants follow a fasting mimicking diet, which is a low-sugar, plant-based, calorie-reduced diet, for four days before each cycle. Treatment cycles repeat every 42 days and may continue for up to two years if there is no disease progression or unacceptable side effects. Throughout the study, patients will have blood samples taken and undergo CT and MRI scans to monitor their health and cancer status. Researchers will track adherence to the diet, side effects, tumor response, and survival outcomes. After completing the treatment phase, patients will have follow-up visits at 30 days and then every three months for up to six months to assess their ongoing health and safety.

Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer