Clinical Trial · NCT01730612

ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA

Overview

Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma. Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;

Sponsor

Nantes University Hospital

Phase

Phase 1/2

Contacts

francoise Bodere, PhD, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01730612

Drug / Compound

IMP-288

Isotope(s):

Target(s):

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Karnofsky ≥ 70 or ECOG 0-1 •• ACE of the tumor by immunohistochemistry or positive plasma CEA ≥ 10 ng / mL
Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment with current consensus
≥ 18 years
Social insurance
creatinine \< 2.5
At least one measurable lesion on CT

Exclusion

Persons protected by law
Not controlled diabetes
Presence of anti-antibodies in patients who have previously received antibodies
Serious illness or co-morbidity risk assessed
Known hypersensitivity to antibodies or proteins
Pregnancy or breastfeeding