TheranosticTrials.org

Clinical Trial · NCT00860860

Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer

Overview

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.

Sponsor

Radboud University Medical Center

Phase

Phase 1

Contacts

R Schoffelen, MD (STUDY_CHAIR)

O C Boerman, PhD (STUDY_CHAIR)

W JG Oyen, MD PhD (PRINCIPAL_INVESTIGATOR)

W TA van der Graaf, MD PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00860860

Drug / Compound

IMP-288

Isotope(s):
Target(s):
  • CEA
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Total bilirubin \< 2 x upper limit of normal (ULN)
  • Serum creatinine \< 2 x ULN
  • Having normal hematological function: Neutrophils \> 1.5 x 109/l; Platelet count \> 150 x 109/l, without transfusion during the previous month; Hemoglobin \> 5.6 mmol/l
  • Cockcroft clearance \> 50 ml/min
  • ASAT, ALAT \< 3 x ULN
  • Negative pregnancy test for women of child¬bearing potential (urine or serum)
  • Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
  • WHO performance status: 0 or 1

Exclusion

  • Life expectancy shorter than 6 months.
  • Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
  • Cardiac disease with New York Heart Association classification of III or IV
  • Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
  • Known metastases to the brain
  • Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
  • Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status