Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
This study tests a combination treatment for colorectal cancer that has spread to other parts of the body. The treatment includes two antibody drugs (botensilimab and balstilimab) combined with a special fasting diet and high-dose vitamin C to see if it can help patients whose cancers have a KRAS mutation.
Key Objective:The trial is testing whether combining these antibody drugs with fasting mimicking diet and vitamin C can safely shrink or control KRAS-mutant metastatic colorectal cancer.
Who to Consider:Patients with metastatic colorectal cancer that has a KRAS mutation and have had limited prior treatment options should consider this trial.
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a Clinical Laboratory Improvement Act \[CLIA\]-certified lab), including metastases to liver, lung, etc. * Disease progression, intolerance or contraindication to a fluoropyrimidine, oxaliplatin, irinotecan * ≥ 18 years of age * Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 * Estimated life expectancy ≥ 3 months * Body mass index (BMI) ≥ 18.5 * Absolute neutrophil count ≥ 1,500/mcL * Hemoglobin ≥ 8.0 g/dL * Platelets ≥ 75,000/mcL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (for patients with Gilbert syndrome ≤ 3.0 x ULN) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN * Creatinine ≤ 1.5 x ULN * Measurable disease as defined by RECIST 1.1 * No history of prior or current malignancy that requires active treatment * Female patients of childbearing potential must b