Trial Information

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