Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130826
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-10-20
Brief Title:
Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy SBRT in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of M5A-IL2 immunocytokine M5A-ICK combined with stereotactic body radiation therapy SBRT and to see how well they work in treating patients with colorectal cancer or xarcinoembryonic antigen CEA positive breast cancer that cannot be removed by surgery unresectable or has spread from where it first started primary site to other places in the body metastatic Carcinoembryonic Antigen CEA is a protein that is present in most colorectal cancers and in many other cancers such as breast cancer as well SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue Cytokines are signaling proteins that help control inflammation in the body They allow the immune system to mount a defense if germs or cancer or other substances that can make people sick enter the body Interleukin-2 IL-2 is a powerful cytokine able to regulate the immune responses that are important for anticancer immunity Immunocytokines also called antibody-cytokine fusion proteins are small proteins that regulate the activity of immune cells The M5A-IL2 immunocytokine M5A-ICK combines the cancer targeting features of the M5A antibody with the immune system regulation properties of the cytokine IL-2 Giving M5A-ICK in combination with standard of care SOC SBRT may work better in treating patients with unresectable metastatic colorectal cancer or CEA positive metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I Identify the maximum tolerated dose MTD and recommend phase 2 dose RP2D and characterize toxicities associated with administration of the M5A-IL2 after fractionated SBRT
SECONDARY OBJECTIVES
I Describe the therapeutic response to treatment of irradiated and unirradiated tumors per Criteria in Solid Tumors version 11 RECIST v 11 guidelines
II Describe AEs by M5A-IL2 dose level per Common Terminology Criteria for Adverse Events CTCAE version 50
III Describe the pharmacokinetics of M5A-IL2 IV Describe the frequency of auto-antibody formation overall and by dose of M5A-IL2
EXPLORATORY OBJECTIVE
I If medically feasible tumors targeted for SBRT will be biopsied pre-SBRT and 1-2 weeks post 3rd dose of M5A-IL2
OUTLINE This is a dose-escalation study of M5A-ICK
Patients undergo SOC SBRT over 3 fractions on days 1 3 and 5 followed by M5A-ICK subcutaneously SC on days 8 9 and 10 once daily for a single cycle on study Patients undergo computed tomography CT or positron emission tomography PETCT as well as blood sample collection throughout the trial Patients may undergo magnetic resonance imaging or bone scan as clinically indicated on the trial Additionally patients may optionally undergo tissue biopsy during screening and on study
After completion of study treatment patients are followed-up at 3 months
I Identify the maximum tolerated dose MTD and recommend phase 2 dose RP2D and characterize toxicities associated with administration of the M5A-IL2 after fractionated SBRT
SECONDARY OBJECTIVES
I Describe the therapeutic response to treatment of irradiated and unirradiated tumors per Criteria in Solid Tumors version 11 RECIST v 11 guidelines
II Describe AEs by M5A-IL2 dose level per Common Terminology Criteria for Adverse Events CTCAE version 50
III Describe the pharmacokinetics of M5A-IL2 IV Describe the frequency of auto-antibody formation overall and by dose of M5A-IL2
EXPLORATORY OBJECTIVE
I If medically feasible tumors targeted for SBRT will be biopsied pre-SBRT and 1-2 weeks post 3rd dose of M5A-IL2
OUTLINE This is a dose-escalation study of M5A-ICK
Patients undergo SOC SBRT over 3 fractions on days 1 3 and 5 followed by M5A-ICK subcutaneously SC on days 8 9 and 10 once daily for a single cycle on study Patients undergo computed tomography CT or positron emission tomography PETCT as well as blood sample collection throughout the trial Patients may undergo magnetic resonance imaging or bone scan as clinically indicated on the trial Additionally patients may optionally undergo tissue biopsy during screening and on study
After completion of study treatment patients are followed-up at 3 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-2023-07592 | REGISTRY | None | None |
| 20510 | OTHER | None | None |
| P30CA033572 | NIH | None | None |
| R01CA283603 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchR01CA283603 |