HER2 Negative Breast Carcinoma Expressing CEA Clinical Trial
Official 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
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;
- 4 or 5 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different
interval time. A last cohort (4 or 5 ): maximum of 21 additional patients with the
optimal schedule.
Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours
Cohort II: based on the results of the cohort I :
1. Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6
nmol of IMP-288 / 30 hours
2. Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 /
18 hours
3. Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 /
3nmol IMP- 288 / 24 hours
Cohort III: based on results of cohort II:
- Good signal of the tumor : dose reduction, 120 nmol TF2 / 3 nmol IMP-288 / 30 h
Cohort IV : based on results of cohort III Cohort V : Based on results of cohort IV
• A last Cohort (VI) : 19 patients with the optimal schedule of injection : 120 nmol TF2
/ 3 nmol IMP-288 / 30 h or 120 nmol TF2 / 6 nmol IMP-288 / 30 h
• In the four weeks prior to the immuno-PET:
- Clinical examination,
- CEA and CA15-3,
- thoraco abdominal pelvic scan, bone scan, FDG-PET,
- immunohistochemistry ACE on the tumor if possible,
- Anti-Antibodies if the patient has already received MAb,
- pregnancy test within 2 days prior to immuno-PET,
- (creatinine > 2.5 normal) D0: Injection of TF2 D1 to D4: injection of 68 Ga-IMP-288
(depending of the cohort) D0 to D4 : pharmacokinetics, imaging
Evaluation at 1 month of Immuno-PET:
• Assessment of the clinical oncologist and
- histological biopsy and / or surgery performed according to the results of imaging and
assessment of the potential clinical impact
Evaluation at 3 and 6 months of immuno-PET:
based on the results of immuno-PET, evaluation and therapeutic decision of the
oncologist,
- Imaging (ultrasound, bone scintigraphy, CT or PET FDG),
- markers
- Anti-Antibody Search
- For patient with a cancer treatment a new immuno-PET can be proposed
;