Actively Recruiting
A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet Plus Vitamin C in Patients With KRAS-Mutant Metastatic Colorectal Cancer
Led by University of Southern California · Updated on 2026-03-17
15
Participants Needed
3
Research Sites
52 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
Researchers are evaluating the safety, side effects, and potential effectiveness of combining botensilimab and balstilimab with a fasting mimicking diet and high dose vitamin C in patients with KRAS-mutant metastatic colorectal cancer. This phase Ib trial aims to study how this combination may impact tumor growth and spread, focusing on patients whose cancer cells have a specific KRAS mutation that might respond differently to vitamin C and dietary changes. Patients receive botensilimab intravenously over 30 minutes on day 1 of each 42-day cycle for up to four cycles. Balstilimab and vitamin C are given intravenously on days 1, 15, and 29 of each cycle. Participants follow a fasting mimicking diet, which is a low-sugar, plant-based, calorie-reduced diet, for four days before each cycle. Treatment cycles repeat every 42 days and may continue for up to two years if there is no disease progression or unacceptable side effects. Throughout the study, patients will have blood samples taken and undergo CT and MRI scans to monitor their health and cancer status. Researchers will track adherence to the diet, side effects, tumor response, and survival outcomes. After completing the treatment phase, patients will have follow-up visits at 30 days and then every three months for up to six months to assess their ongoing health and safety.
CONDITIONS
Brief 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 a fluoropyrimidine, oxaliplatin, or irinotecan
- Age 18 years or older
- ECOG performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Body mass index of 18.5 or higher
- Adequate blood counts and organ function as defined by specific laboratory values
- Measurable disease by RECIST 1.1 criteria
- No active malignancy requiring treatment
- Female participants of childbearing potential must use effective contraception and have a negative pregnancy test
- Male participants with female partners of childbearing potential must use effective contraception
You will not qualify if you...
- Current diagnosis of diabetes mellitus
- Use of medications that cannot be safely stopped during fasting or that require food intake
- Recent systemic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose
- History of syncope with caloric restriction or medical conditions making fasting unsafe
- Current use of oral vitamin C supplements
- Participation in another investigational study within 3 weeks
- Expected need for other cancer therapies during the trial
- History of anti-PD1 or anti-CTLA4 therapy
- Unresolved toxicities of grade 2 or higher except neuropathy or alopecia
- Untreated or symptomatic brain metastases
- Significant electrolyte imbalances
- Conditions predisposing to hemolysis such as G6PD deficiency
- History of oxalate kidney stones
- Major surgery within 4 weeks prior to immunotherapy
- Severe hypersensitivity to monoclonal antibodies or immuno-oncology agents
- Bleeding disorders or coagulopathy
- Use of systemic corticosteroids or immunosuppressants within 1 week prior to study drug
- Active autoimmune disease requiring systemic treatment within 2 years
- History of allogeneic tissue or solid organ transplant except corneal
- Legal incapacity or limited legal capacity
- Uncontrolled illness such as active infection, heart failure, recent heart attack or stroke, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years in the absence of disease progression or unacceptable toxicity
Participants receive botensilimab intravenously on day 1 of each 42-day cycle for up to 4 cycles. Balstilimab and vitamin C are given intravenously on days 1, 15, and 29 of each cycle. Participants follow a fasting mimicking diet on days -4 to -1 of each cycle. Blood samples, CT scans, and MRI are collected during the study.
Infusions on days 1, 15, and 29 of each 42-day cycle; fasting mimicking diet for 4 days before each cycle
Duration - Up to 6 months
After completing treatment, participants are followed up at 30 days and every 3 months for up to 6 months to monitor health and outcomes.
1 visit at 30 days and quarterly visits every 3 months
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
R
Rabia Rehman
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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