RecruitingPhase 1NCT06336902

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

A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet (FMD) Plus Vitamin C in Patients With KRAS-Mutant Metastatic Colorectal Cancer


Sponsor

University of Southern California

Enrollment

15 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs (botensilimab and balstilimab) together with a fasting-mimicking diet and vitamin C in people with metastatic colorectal cancer that carries a specific mutation (any KRAS mutation) and is of the microsatellite stable (MSS) subtype — a cancer type that typically doesn't respond well to immunotherapy alone. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of MSS metastatic colorectal adenocarcinoma with a KRAS mutation - Your cancer has progressed on or you cannot tolerate standard chemotherapy regimens (fluoropyrimidine, oxaliplatin, and irinotecan) - You have a good performance status (ECOG 0–1), a life expectancy of at least 3 months, and a BMI of 18.5 or above - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have had prior treatment with either of the study immunotherapy drugs - You have active autoimmune disease or have received high-dose steroids recently - You have significant heart, liver, or kidney dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBalstilimab

Given IV

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALBotensilimab

Given IV

PROCEDUREComputed Tomography

Undergo CT scan

OTHERDietary Intervention

Undergo FMD

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DIETARY_SUPPLEMENTVitamin C

Given IV


Locations(3)

Saint Jude Medical Center / Providence Medical Foundation

Fullerton, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

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NCT06336902


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