Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer (PRIT2008)

Radboud University Medical Center

Status and phase

Completed

Phase 1

Conditions

Colorectal Neoplasms

Treatments

Drug: IMP-288 labeled with In111 and Lu177

Drug: TF2

Study type

Interventional

Funder types

Other

Identifiers

NCT00860860

RUNMC-PRIT2008

Details and patient eligibility

About

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.

Full description

Pretherapy cycle with IMP-288 labeled In111.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.