HER2 Negative Breast Carcinoma Expressing CEA Clinical Trial
— iTEPseinOfficial title:
Pilot Study for Optimization of Immuno-PET Pretargeted With Anti-CEA Bispecific Antibody X Anti-HSG TF2 and the Peptide IMP-288 Radiolabeled With Gallium-68 -Pharmacokinetic and Imaging for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
| Verified date | May 2017 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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;
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | May 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment with current consensus - = 18 years - Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective contraception continuously for 3 months. - Karnofsky = 70 or ECOG 0-1 •• ACE of the tumor by immunohistochemistry or positive plasma CEA = 10 ng / mL - At least one measurable lesion on CT - creatinine < 2.5 - Informed consent signed - Social insurance Exclusion Criteria: - Pregnancy or breastfeeding - Serious illness or co-morbidity risk assessed - History of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix - Presence of anti-antibodies in patients who have previously received antibodies - Known hypersensitivity to antibodies or proteins - intellectual disability to sign the informed consent - Not controlled diabetes - Persons protected by law |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospital | Nantes | |
| France | Institut de Cancérologie de l'Ouest | Saint Herblain |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital | Immunomedics, Inc., Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | • To assess the tolerance of 150 MBq of 68 Ga-IMP-288 | 6 months | ||
| Other | To search for the development of immunization with TF2 and the complex TF2-IMP-288: ELISA | 6 months | ||
| Primary | evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288 | Pk blood after injections of TF2 and 68 Ga-IMP-288 and PET imaging semi-quantification with 60 to 120 minutes after injection of 68 Ga-IMP-288 | One week | |
| Secondary | Sensibility, tolerance | sensitivity of the immuno-PET and compare its performance to standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months by RECIST and EORTC | 6 months after immunoTEP | |
| Secondary | To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods | 6 weeks after initiation of treatment of metastases (after the first iTEP), a second _iTEP with a therapeutic evaluation will be carried out. The examination requirements are identical to those of the first immunoTEP. this second iITEP will be evaluated in regard of imaging assessment performed routinely (TAP scanner, FDG-PET, CA15-3 and CEA) |
month 6 |