Clinical trial · Interventional
ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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;
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Negative Breast Carcinoma Expressing CEA | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TF2 - 68 Ga-IMP-288: | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288
- timeFrame
- One week
- description
- 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
Secondary outcomes (2)
- measure
- Sensibility, tolerance
- timeFrame
- 6 months after immunoTEP
- description
- 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
- measure
- To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods
- timeFrame
- month 6
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available