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Botensilimab, Balstilimab, and Diet for KRAS-Mutant Colorectal Cancer

This study is testing a new approach for people with metastatic colorectal cancer that has a specific change called a KRAS mutation. It combines two medications, botensilimab and balstilimab, with a special eating plan called a fasting mimicking diet (FMD) and high-dose vitamin C. Botensilimab and balstilimab are antibodies that may help stop cancer cells from growing. The FMD is a plant-based, low-calorie diet that might make cancer treatments work better, especially since KRAS-mutant cells may be more sensitive to vitamin C when sugar is low. This study aims to see how safe this combination is, if patients can follow the diet, and if it helps shrink tumors. You may be able to join if you have KRAS-mutant metastatic colorectal cancer that has progressed or you can't take certain standard treatments.

Study design
This is a Phase 1b interventional study, meaning it's an early-stage trial focusing on safety and dosage. It plans to enroll 15 participants.
What's involved
You would receive botensilimab and balstilimab intravenously (through a vein), undergo a fasting mimicking diet, and have blood samples and CT scans taken. This would continue for at least two cycles of therapy.
Compensation
Not stated in the trial record.
Follow-up
The study will track your health and any side effects for up to 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06336902

Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Southern California
~15 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:BalstilimabBiospecimen CollectionBotensilimabComputed TomographyDietary InterventionMagnetic Resonance Imaging

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who adhere to the fast mimicking diet
Measured over Up to 30 months
+1 more outcome measured

Conditions

Metastatic Colorectal Adenocarcinoma
Stage IV Colorectal Cancer AJCC v8

Explore related trials

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Where it's being run

3 sites across 1 states
California3

Study leadership

  • Diana Hanna, MD · PRINCIPAL_INVESTIGATOR · University of Southern California

Who to contact

Charlean Ketchens, RN
[email protected]
323-865-0451
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 be willing to use highly effective contraceptive measures starting with the Screening visit through 90 days after last dose of study treatment.
Female patients of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication). Non-childbearing potential is defined as 1 of the following:
≥ 45 years of age and has not had menses for \> 1 year
Amenorrheic for \> 2 years without a hysterectomy and/or oophorectomy and follicle stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
Status is post-hysterectomy, -oophorectomy, or -tubal ligation
Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.

Exclusion

Patients with a current diagnosis of diabetes mellitus are not eligible for this study.
Patients taking medications that cannot be safely stopped during the fasting periods or which may not be safely taken without food are not eligible for this study
Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or major surgery within 3 weeks prior to first dose of study drug. A 1-week washout is permitted for palliative radiation to non-central nervous system (CNS) disease, with approval from the principal investigator
History of syncope with caloric restriction or another medical comorbidity which would make fasting potentially dangerous
Current use of oral vitamin C supplements
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
Expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection)
History of anti-PD1 or anti-CTLA4 therapy
Unresolved toxicity ≥ CTCAE grade 2 except for neuropathy, alopecia
Untreated brain or leptomeningeal metastases or previously treated CNS metastases with any of the following: residual neurologic deficit; history of seizures; ongoing requirement of steroids, exceeding prednisone 10 mg daily dose
Patients who have uncontrolled or severe hyponatremia, hypernatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hypokalemia, hyperkalemia, hypomagnesemia, or hypermagnesemia
Patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, hereditary spherocytosis, or other conditions predisposing patient to hemolysis
Patients who have a history of oxalate renal calculi
Major surgery within 4 weeks of first dose of immunotherapy
Known severe (grade ≥ 3) hypersensitivity reactions to fully human monoclonal antibodies, antibody, or severe reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment with steroids; or has a history of interstitial lung disease, any history of anaphylaxis, or uncontrolled asthma
Evidence of bleeding diathesis or clinically significant coagulopathy
Receiving systemic corticosteroid therapy 1 week prior to the first dose of study drug or receiving any other form of systemic immunosuppressive medication.
Active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Has had an allogeneic tissue/solid organ transplant, except for corneal transplants
Legally incapacitated or has limited legal capacity
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active coronary artery disease, myocardial infarction or cerebrovascular accident within 6 months prior to study entry, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

What this trial measures

  • Proportion of patients who adhere to the fast mimicking dietUp to 30 months

    Adherence will be defined as the percentage of patients who adhere to the fasting-mimicking diet ≥ 75% of the designated days and receive all doses of study drugs for at least any 2 cycles of therapy during the course of the study. Adherence will be reported overall and by cycle started.

  • Incidence of adverse events (AEs)Up to 30 months

    The frequency and severity of treatment-related events will be assessed using Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be used to summarize AEs including counts for categorical measures and means for continuous measures. Incidence of AEs will be reported overall and by cycle started.