protocolSection identificationModule nctId: NCT06336902, orgStudyIdInfo id: 3C-23-11, secondaryIdInfos id: NCI-2024-01368, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 3C-23-11, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule 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., conditionsModule conditions: Metastatic Colorectal Adenocarcinoma, conditions: Stage IV Colorectal Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Balstilimab, interventions name: Biospecimen Collection, interventions name: Botensilimab, interventions name: Computed Tomography, interventions name: Dietary Intervention, interventions name: Magnetic Resonance Imaging, interventions name: Vitamin C, outcomesModule primaryOutcomes measure: Proportion of patients who adhere to the fast mimicking diet, primaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Los Angeles General Medical Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Charlean Ketchens, RN, role: CONTACT, phone: 323-865-0451, email: Charlean.Ketchens@med.usc.edu, contacts name: Rabia Rehman, role: CONTACT, phone: 323-865-0451, email: Rabia.Rehman@med.usc.edu, contacts name: Diana Hanna, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: USC / Norris Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Charlean Ketchens, RN, role: CONTACT, phone: 323-865-0451, email: Charlean.Ketchens@med.usc.edu, contacts name: Rabia Rehman, role: CONTACT, phone: 323-865-0451, email: Rabia.Rehman@med.usc.edu, contacts name: Diana Hanna, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False