Study of TF2 Carcinoembryonic Antigen (CEA) Antibody in Patients With Metastatic Colorectal Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Safety [ Time Frame: Safety will be measured routinely during the 3 weeks of administration and afterwards during follow-up for up to 5 years ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
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.
|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|