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
• 3 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different interval
time. A last cohort (4): 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:
Situation 1 in cohort II
- Good signal of the tumor : dose reduction, 60 nmol TF2 / 3 nmol IMP-288 / 30 h
- Low signal of the tumor : dose reduction, 60 TF2 nmol /3 nmol IMP- 288 / 24 h
Situation 2 in Cohort II
- Good signal of the tumor : dose reduction, 60 nmol TF2 / 3 nmol IMP-288 / 18 h
- Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol
IMP-288 / 8 h
Situation 3 in Cohort II - Good signal of the tumor: dose reduction, 30 nmol TF2 / 1.5
nmol of IMP-288 / 24 h
- Low signal of the tumor: reduction of the interval time, 60 nmol TF2 / 3 nmol IMP-288
/ 18 h
Cohort IV: 21 patients with the optimal schedule
• 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 : pharmacocinetics, 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
Inclusion criteria:
• Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment
with Anthracyclines and Taxanes (neoadjuvant or adjuvant or metastatic)
• ≥ 18 years
• Negative pregnancy test for women of childbearing age. Women of childbearing age
should take effective contraception continuously for 3 months.
• At least 4 weeks after the previous treatment and after recovery of toxicity
• Karnofsky ≥ 70 or ECOG 0-1
• Life expectancy of at least 6 months
• 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
- diabetes
- Persons protected by law
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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
No
francoise Bodere, PhD, MD
Principal Investigator
Nantes Hospital
France : ANSM
BRD 10/4-O
NCT01730612
December 2012
December 2014
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