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This is a Phase I trial to study the safety of IMMU-130. IMMU-130 is composed of a drug attached to an antibody. The drug is the active ingredient in irinotecan which is a common chemotherapy drug used for colorectal cancer. Antibodies are proteins normally made by the immune system. They bind to substances that don't belong in the body to prevent harm to the body. The antibody in this study was designed to bind to a marker located on colorectal cancer tumors. The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies. This study will investigate how IMMU-130 acts for the treatment of colorectal cancer. The study is mainly being done to see if IMMU-130 is safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMMU-130 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMMU-130 | Drug | IMMU-130 will be administered intravenously every 2 weeks for up to 6 months or longer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The primary outcome measured will be safety of IMMU-130 administered at different dose levels. Safety will be assessed by reviewing the number of adverse events and overall toxicity. | Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy | The secondary objectives are to assess pharmacokinetics and immunogenicity, and to obtain preliminary information on efficacy with this dosing schedule. Efficacy will be assessed using CT scan imaging. | Efficacy will be measured every 8-12 weeks during treatment and every 6 months during the 2nd year and then annually up to 5 years thereafter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000624221 | labetuzumab govitecan |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |