Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer (RITCOLON)
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|ClinicalTrials.gov Identifier: NCT02300922|
Recruitment Status : Unknown
Verified January 2017 by Nantes University Hospital.
Recruitment status was: Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : January 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Antibody TF2 Drug: 90-Y-IMP-288 Drug: 111-In-IMP-288||Phase 1 Phase 2|
This study investigates a pretargeted radioimmunotherapy (pRAIT) with the anti-carcinoembryonic antigen (CEA) TF2 bispecific monoclonal antibody (BsMAb) and the 90Y-IMP288 radio-labeled peptide.
TF2 will be given once a week for 3 successive weeks at 75 mg/m2 per dose. IMP288 will be given 3 times, 1 day after each TF2 injection. IMP288 will be radio-labeled with 111In (imaging) for the first injection and then 90Y (therapy) for the 2 subsequent injections.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Experimental: several cohorts
All patients will receive 3 injections of TF2 (the first: 14 mg/m², the second and the third:75 mg/m²). One day after each injection of TF2, the patient will receive a radiolabelled peptide (IMP-288) with Yttrium for therapeutic injectionThe First cohort will receive 555 MBq/m2 X 2 of 90-Y-IMP-288.:
All patient will receive 180 MBq of 111-In-IMP-288 for dosimetry analysis
Drug: Antibody TF2
injection of a recombinant antibody CEA specific. Three injections. Each injection are separate by one week
Injection of the peptide 90-Y-IMP-288, 24 Hours after injection of TF2. 2 injections by patients separated by one week (week 2 and week 3)
Injection of the peptide 111-In-IMP-288, 24 Hours after the first injection of TF2 (week 1)
- To determine the maximum tolerated dose for 90Y-IMP288. [ Time Frame: Week 6 to week 12 ]toxicity analysis
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): NCT02300922
|CHU de Nantes|
|Nantes, France, 44093|