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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860860 on ClinicalTrials.gov