Study of TF2 Carcinoembryonic Antigen (CEA) Antibody in Patients With Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT01273402|
Recruitment Status : Terminated (A new study is being designed. No patients were enrolled.)
First Posted : January 10, 2011
Last Update Posted : September 25, 2012
This study is being done to select an appropriate TF2 bsMAb dose suitable for pretargeting the 111In/90Y-labeled hapten-peptide (IMP-288). Eligible patients will receive a fixed dose of 90Y-IMP-288 4 days after the TF2 antibody injection. Two different dose levels of TF2 will be studied in the first part.
Once an appropriate TF2 dose is selected based on information learned from the first 2 dose levels, patients will be enrolled onto several different increasing dose levels of 90Y-IMP-288.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: TF2/IMP288||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pretargeted Radioimmunotherapy of Colorectal Cancer: A Phase I Study to Determine Dose-limiting Toxicity and Maximum Tolerated Dose of an Anti-CEACAM5 bsMAb-pretargeted 90Y-hapten-peptide|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||August 2018|
Experimental: TF2 and IMP288
TF2 will be administered at least 4 days before the radiolabeled IMP-288.
TF2 is administered 4 days prior to radiolabeled IMP288. Each are given weekly for 2 weeks.
- Safety [ Time Frame: Safety will be measured routinely during the 3 weeks of administration and afterwards during follow-up for up to 5 years ]Safety will be assessed by determing the number of participants with Adverse Events as a Measure of Safety and Tolerability.
- Efficacy will be evaluating using CT scans and possibly PET imaging. [ Time Frame: Efficacy will be measured at 4 and 8 weeks after treatment and every 3 months for up to 2 years. ]CT scans will primarily be used to assess tumor response and to assess the change in tumor size from baseline for up to 2 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273402
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20057|
|Principal Investigator:||Robert Sharkey, PhD||Garden State Cancer Center/Center for Molecular Medicine and Immunology|