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

Phase 1

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT00860860
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Pretherapy cycle with IMP-288 labeled In111.

Study Timeline

• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Start: 2009-07
• Status Verified: 2010-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available
• WHO performance status: 0 or 1
• 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
• Total bilirubin < 2 x upper limit of normal (ULN)
• ASAT, ALAT < 3 x ULN
• Serum creatinine < 2 x ULN
• Cockcroft clearance > 50 ml/min
• Negative pregnancy test for women of child¬bearing potential (urine or serum)
• Age over 18 years
• Ability to provide written informed consent

Exclusion Criteria

• 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.
• Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks
• Cardiac disease with New York Heart Association classification of III or IV
• Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
• 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
• Life expectancy shorter than 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0	first three weeks: daily, thereafter: weekly

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics and biodistribution of TF2 and Lu-177-labeled IMP-288, sensitivity of pretargeted imaging with In-111-labeled IMP-288, and tumor response using RECIST criteria	Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands