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TF2 - 68 Ga-IMP-288:

Phase 1

HER2 Negative Breast Carcinoma Expressing CEA | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Jul 27, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01730612ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEAPHASE1 COMPLETED 23 — — Dec 1, 2012May 1, 2017Jul 27, 20182 France
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Study Endpoints
Primary Endpoints
evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288
One week

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 Endpoints
Sensibility, tolerance
6 months after immunoTEP
To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods
month 6
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
TF2 - 68 Ga-IMP-288:DRUGImmunoTEP
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

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. * Karnofs...

Countries:France
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