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Monoclonal Antibodies

Botensilimab + Balstilimab and Diet + Vitamin C for Colorectal Cancer

Phase 1

Waitlist Available

Led By Diana Hanna, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of combining two monoclonal antibodies, botensilimab and balstilimab, with a fasting mimicking diet and high dose vitamin C for

Who is the study for?

This trial is for patients with metastatic colorectal cancer that has a specific mutation called KRAS. Participants should be interested in combining standard cancer treatments with dietary changes and vitamin supplements.

What is being tested?

The trial is testing the combination of two monoclonal antibodies, Botensilimab and Balstilimab, alongside a special low-sugar diet designed to mimic fasting and high doses of Vitamin C. The goal is to see if this combo can help stop the growth and spread of cancer cells more effectively.

What are the potential side effects?

Potential side effects may include typical reactions to antibody treatment such as allergic responses or infusion-related discomforts, as well as effects from dietary changes like fatigue or digestive upset due to the fasting mimicking diet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Proportion of patients who adhere to the fast mimicking diet

Secondary study objectives

Overall response rate (ORR)

Overall survival (OS)

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (botensilimab, balstilimab, FMD, vitamin C)Experimental Treatment7 Interventions

Patients receive botensilimab IV over 30 minutes on day 1 of each cycle for up to 4 cycles. Patients receive balstilimab IV over 30 minutes and vitamin C IV over 30 minutes on days 1, 15 and 29 of each cycle. Patients undergo a FMD on days -4 to -1 of each cycle. Cycles repeat every 42 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT scans and MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Balstilimab

2023

Completed Phase 1

~20