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

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

Trial Details

NCT ID

NCT06336902

Phase

PHASE1

Sponsor

University of Southern California

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

Balstilimab
Biospecimen Collection
Botensilimab
Computed Tomography
Dietary Intervention
Magnetic Resonance Imaging

Locations (sample)

Fullerton, California, United States|33.87029,-117.92534
Los Angeles, California, United States|34.05223,-118.24368
Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

Histologically or cytologically confirmed microsatellite stable (MSS) metastatic colorectal adenocarcinoma with any KRAS mutation (as determined by…
Disease progression, intolerance or contraindication to a fluoropyrimidine, oxaliplatin, irinotecan
≥ 18 years of age
Performance status Eastern Cooperative Oncology Group (ECOG) 0-1

For full eligibility, visit ClinicalTrials.gov.

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