Actively Recruiting
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
Led by University of Southern California · Updated on 2026-03-17
15
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed microsatellite stable metastatic colorectal adenocarcinoma with any KRAS mutation
- Disease progression, intolerance, or contraindication to fluoropyrimidine, oxaliplatin, or irinotecan
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Body mass index of 18.5 or higher
- Absolute neutrophil count of at least 1,500/mcL
- Hemoglobin level of at least 8.0 g/dL
- Platelet count of at least 75,000/mcL
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), or up to 3.0 times ULN for Gilbert syndrome
- AST and ALT levels less than or equal to 3 times ULN
- Creatinine less than or equal to 1.5 times ULN
- Measurable disease per RECIST 1.1
- No history of other malignancy requiring active treatment
- Female patients of childbearing potential must use highly effective contraception during the study and have a negative pregnancy test before starting
- Male patients with partners of childbearing potential must use highly effective contraception during the study
You will not qualify if you...
- Current diagnosis of diabetes mellitus
- Taking medications that cannot be safely stopped during fasting periods or taken without food
- Received chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose (except 1-week washout for certain radiation)
- History of syncope with caloric restriction or other medical issues making fasting unsafe
- Current use of oral vitamin C supplements
- Participation in other investigational studies within 3 weeks prior to first dose
- Expected need for other systemic or localized cancer treatments during the trial
- History of anti-PD1 or anti-CTLA4 therapy
- Unresolved toxicities grade 2 or higher except neuropathy or alopecia
- Untreated brain or leptomeningeal metastases or treated CNS metastases with residual issues
- Uncontrolled electrolyte imbalances
- Glucose-6-phosphate dehydrogenase deficiency or other hemolysis-prone conditions
- History of oxalate kidney stones
- Major surgery within 4 weeks prior to immunotherapy
- Severe hypersensitivity or allergic reactions to monoclonal antibodies or immuno-oncology agents
- Bleeding or clotting disorders
- Systemic corticosteroid or immunosuppressive therapy within 1 week prior to first dose, with some exceptions
- Active or recent autoimmune disease requiring systemic treatment
- History of allogeneic tissue or solid organ transplant except corneal
- Legal incapacity
- Uncontrolled illnesses including infections, heart failure, recent heart attack or stroke, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Saint Jude Medical Center / Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
C
Charlean Ketchens, RN
CONTACT
R
Rabia Rehman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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