A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT01915472|
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : August 5, 2013
Last Update Posted : August 19, 2021
Information provided by (Responsible Party):
This is a Phase II trial to study the safety and efficacy 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 The antibody was originally made from mouse proteins, but was changed in the laboratory to be more like human antibodies.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 and effective.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: IMMU 130||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of IMMU 130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Metastatic Colorectal Cancer|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
|Experimental: IMMU 130||
Drug: IMMU 130
This is a Phase II, open-label study of IMMU-130 administered every 14 days for a period of 24 weeks to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.
Primary Outcome Measures :
- Safety [ Time Frame: Safety will be measured routinely during the 6 months of administration and afterwards during follow-up for up to 5 years ]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.
Secondary Outcome Measures :
- Assess PK [ Time Frame: Efficacy will be measured every 8 weeks during treatment and every 3 months during the 1st year and then every 6 months up to 5 years thereafter. ]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.
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