nctId: NCT06336902 id: 3C-23-11 id: NCI-2024-01368 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 3C-23-11 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-04-01 date: 2024-03-29 date: 2024-03-29 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: 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. conditions: Metastatic Colorectal Adenocarcinoma conditions: Stage IV Colorectal Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Balstilimab name: Biospecimen Collection name: Botensilimab name: Computed Tomography name: Dietary Intervention name: Magnetic Resonance Imaging name: Vitamin C measure: Proportion of patients who adhere to the fast mimicking diet measure: Incidence of adverse events (AEs) measure: Overall response rate (ORR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Los Angeles General Medical Center city: Los Angeles state: California zip: 90033 country: United States name: Charlean Ketchens, RN role: CONTACT phone: 323-865-0451 email: Charlean.Ketchens@med.usc.edu name: Rabia Rehman role: CONTACT phone: 323-865-0451 email: Rabia.Rehman@med.usc.edu name: Diana Hanna, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: USC / Norris Comprehensive Cancer Center city: Los Angeles state: California zip: 90033 country: United States name: Charlean Ketchens, RN role: CONTACT phone: 323-865-0451 email: Charlean.Ketchens@med.usc.edu name: Rabia Rehman role: CONTACT phone: 323-865-0451 email: Rabia.Rehman@med.usc.edu name: Diana Hanna, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False