drugset / Trial / NCT01730612
ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
Phase 1/2
Completed
23 enrolled
Nantes University Hospital
Gilead Sciences · collabInstitut National de la Santé Et de la Recherche Médicale, France · collab
NaSingle-groupOpen-labelDiagnostic
Summary
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;
Timeline
- Start
- 2012-12
- Primary completion
- 2017-05
- Completion
- 2017-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68 Ga-IMP-288 | Peptide | 3 unknown | Other |
| Subject | 68 Ga-IMP-288 | Peptide | 6 unknown | Other |
| Subject | 68 Ga-IMP-288 | Peptide | 150 mbq | Other |
| Subject | TF2 | Monoclonal antibody | 60 unknown | Other |
| Subject | TF2 | Monoclonal antibody | 120 unknown | Other |