Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-21
Brief Title:
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet FMD Plus Vitamin C in Patients With KRAS-Mutant Metastatic Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the feasibility of the fasting mimicking diet FMD when combined with vitamin C and botensilimab plus balstilimab by determining the proportion of patients who adhere to the FMD 75 of the designated days and receive all doses of botensilimab balstilimab and Vitamin C for at least any two cycles of therapy
II To characterize the safety and tolerability of FMD and vitamin C when combined with botensilimab and balstilimab by assessing any grade toxicities per Common Terminology Criteria for Adverse Events CTCAE 50
SECONDARY OBJECTIVES
I To obtain a preliminary assessment of anti-tumor activity of botensilimab plus balstilimab and FMD plus vitamin C by determining the overall response rate using Response Evaluation Criteria in Solid Tumors RECIST 11
II To estimate the progression-free and overall survival in patients with KRAS-mutant colorectal cancer CRC receiving botensilimab plus balstilimab and FMD plus vitamin C
EXPLORATORY OBJECTIVES
I To characterize circulating tumor deoxyribonucleic acid ctDNA and ctDNA methylation TET Wnt JAKSTAT PI3KAKT CXCR ALDH AMPK profiles at baseline on treatment and at disease progression
II To examine metabolomic markers IGF-1 GAPDH DHA GLUT-1 iron signaling at baseline on treatment and at disease progression
OUTLINE
Patients receive botensilimab intravenously 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 computed tomography CT scans and magnetic resonance imaging MRI throughout the study
After completion of study intervention patients are followed up at 30 days and every 3 months for up to 6 months
I To evaluate the feasibility of the fasting mimicking diet FMD when combined with vitamin C and botensilimab plus balstilimab by determining the proportion of patients who adhere to the FMD 75 of the designated days and receive all doses of botensilimab balstilimab and Vitamin C for at least any two cycles of therapy
II To characterize the safety and tolerability of FMD and vitamin C when combined with botensilimab and balstilimab by assessing any grade toxicities per Common Terminology Criteria for Adverse Events CTCAE 50
SECONDARY OBJECTIVES
I To obtain a preliminary assessment of anti-tumor activity of botensilimab plus balstilimab and FMD plus vitamin C by determining the overall response rate using Response Evaluation Criteria in Solid Tumors RECIST 11
II To estimate the progression-free and overall survival in patients with KRAS-mutant colorectal cancer CRC receiving botensilimab plus balstilimab and FMD plus vitamin C
EXPLORATORY OBJECTIVES
I To characterize circulating tumor deoxyribonucleic acid ctDNA and ctDNA methylation TET Wnt JAKSTAT PI3KAKT CXCR ALDH AMPK profiles at baseline on treatment and at disease progression
II To examine metabolomic markers IGF-1 GAPDH DHA GLUT-1 iron signaling at baseline on treatment and at disease progression
OUTLINE
Patients receive botensilimab intravenously 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 computed tomography CT scans and magnetic resonance imaging MRI throughout the study
After completion of study intervention patients are followed up at 30 days and every 3 months for up to 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01368 | REGISTRY | None | None |
| 3C-23-11 | OTHER | None | None |
| P30CA014089 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA014089 |