Phase I clinical study of the feasibility of pretargeted radioimmunotherapy of an anti-CEA bispecific antibody and Lu-177 labeled peptide in patients with advanced colorectal cancer

Completed

• Conditions: colorectal neoplasms; large bowel cancer; 10017991

• Registration Number: NL-OMON32192
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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 funtion:
• Neutrophils > 1.5 x 109/l
• Platelet count > 150 x 109/l, without transfusion
• Hemoglobin > 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: Not specified