Condition: Metastatic Colorectal Adenocarcinoma · Stage IV Colorectal Cancer AJCC v8 · Sponsor: University of Southern California
This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer.
This description comes directly from the study's public registry record.
Charlean Ketchens, RN · 323-865-0451 · Charlean.Ketchens@med.usc.edu
Rabia Rehman · 323-865-0451 · Rabia.Rehman@med.usc.edu
Always discuss trial participation with your own doctor first.
| Saint Jude Medical Center / Providence Medical Foundation | Fullerton, California, United States | Recruiting |
| Los Angeles General Medical Center | Los Angeles, California, United States | Recruiting |
| USC / Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06336902