Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer
NCT00860860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2012-03-19
Summary
This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.
Conditions
- Colorectal Neoplasms
Interventions
- DRUG
-
TF2
TF2: 75-300 mg
- DRUG
-
IMP-288 labeled with In111 and Lu177
IMP-288: 100 microgram
Sponsors & Collaborators
-
Radboud University Medical Center
lead OTHER
Principal Investigators
-
O C Boerman, PhD · RUNMC Department of Nuclear Medicine
-
R Schoffelen, MD · RUNMC Department of Nuclear Medicine
-
W JG Oyen, MD PhD · RUNMC Department of Nuclear Medicine
-
W TA van der Graaf, MD PhD · RUNMC Department of Medical Oncology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2011-10-31
- Completion
- 2011-10-31
Countries
- Netherlands
Study Locations
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