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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00860860

Acronym

PRIT2008

Enrollment

Registered

2009-03-12

Start date

2009-07-31

Completion date

2011-10-31

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

radioimmunotherapy, pretargeting, bispecific antibody, lutetium 177, phase I clinical trial

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.

Interventions

DRUGTF2

TF2: 75-300 mg

DRUGIMP-288 labeled with In111 and Lu177

IMP-288: 100 microgram

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026