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

Part of paid clinical trials in Fullerton, California.

Sponsor
University of Southern California
Study ID
NCT06336902
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Adenocarcinoma
  • Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Botensilimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Dietary Intervention — OTHER
    Undergo FMD
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Vitamin C — DIETARY_SUPPLEMENT
    Given IV

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Dec 2025
Primary completion
Jan 15, 2027
Completion
Jan 15, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (botensilimab, balstilimab, FMD, vitamin C)
    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.

Primary Outcome Measure

Proportion of patients who adhere to the fast mimicking diet [ Time Frame: Up to 30 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Saint Jude Medical Center / Providence Medical FoundationFullertonCalifornia92835
Maria Diosdado
[email protected]
714-446-5615
David Park, MD (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Charlean Ketchens, RN
[email protected]
323-865-0451
Rabia Rehman
[email protected]
323-865-0451
Diana Hanna, MD (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Charlean Ketchens, RN
[email protected]
323-865-0451
Rabia Rehman
[email protected]
323-865-0451
Diana Hanna, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fullerton, CA

By research site
Saint Jude Medical Center / Providence Medical Foundation· Fullerton, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CA

Related Studies