Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06130826
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Immunotherapy — DRUG
    Receive M5A-IL2 ICK SC
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

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.

Key Dates

First listed
Nov 14, 2023
Start date
May 27, 2025
Status verified
Jul 2026
Primary completion
Sep 5, 2026
Completion
Sep 5, 2026

Study Design

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

Arms

  • Experimental: Treatment (SBRT, M5A-IL2 ICK)
    Patients undergo SOC SBRT over 3 fractions on days 1, 3, and 5, followed by M5A-ICK SC on days 8, 9, and 10 once daily for a single cycle on study. Patients undergo CT or PET/CT 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.

Primary Outcome Measure

Maximum tolerated dose (MTD) of the M5A-IL2 immunocytokine (M5A-ICK) [ Time Frame: At the end of cycle 1 (each cycle is 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Jeffrey Y. Wong
[email protected]
626-256-4673
Jeffrey Y. Wong (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Breast cancerColorectal cancer
By specialty
OncologyBreast oncologyWomen's healthGI oncology
By research site
City of Hope Medical Center· Duarte, CA

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