OncoMatch/Clinical Trials/NCT06336902
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
Is NCT06336902 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Balstilimab and Botensilimab for metastatic colorectal adenocarcinoma.
Treatment: Balstilimab · Botensilimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS any mutation
microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by a Clinical Laboratory Improvement Act [CLIA]-certified lab)
Required: MMR microsatellite stable (microsatellite stable)
microsatellite stable (MSS) metastatic colorectal adenocarcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine
Disease progression, intolerance or contraindication to a fluoropyrimidine
Must have received: oxaliplatin
Disease progression, intolerance or contraindication to oxaliplatin
Must have received: irinotecan
Disease progression, intolerance or contraindication to irinotecan
Cannot have received: anti-PD-1 therapy
History of anti-PD1 or anti-CTLA4 therapy
Cannot have received: anti-CTLA-4 therapy
History of anti-PD1 or anti-CTLA4 therapy
Cannot have received: systemic cytotoxic chemotherapy
Exception: within 3 weeks prior to first dose of study drug
Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug
Cannot have received: biological therapy
Exception: within 3 weeks prior to first dose of study drug
Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug
Cannot have received: radiotherapy
Exception: within 3 weeks prior to first dose of study drug; 1-week washout permitted for palliative radiation to non-CNS disease with PI approval
Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug
Cannot have received: major surgery
Exception: within 3 weeks prior to first dose of study drug
Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug
Cannot have received: major surgery
Exception: within 4 weeks of first dose of immunotherapy
Major surgery within 4 weeks of first dose of immunotherapy
Cannot have received: investigational agent/device
Exception: within 3 weeks of first dose of current study drug
currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of first dose of current study drug
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Hemoglobin ≥ 8.0 g/dL; Platelets ≥ 75,000/mcL
Kidney function
Creatinine ≤ 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 x ULN (for patients with Gilbert syndrome ≤ 3.0 x ULN); AST/ALT ≤ 3 x ULN
Absolute neutrophil count ≥ 1,500/mcL; Hemoglobin ≥ 8.0 g/dL; Platelets ≥ 75,000/mcL; Total bilirubin ≤ 1.5 x ULN (for patients with Gilbert syndrome ≤ 3.0 x ULN); AST/ALT ≤ 3 x ULN; Creatinine ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Saint Jude Medical Center / Providence Medical Foundation · Fullerton, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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