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GSK Biologicals' 719125

Phase 1

Neoplasms, Breast | Monoclonal antibody | Oncology |GSK plc|Last Updated: Dec 27, 2019

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment3
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00140738Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast CancerPHASE1 COMPLETED 3 — — Mar 10, 2005Sep 29, 2009Dec 27, 201914 Belgium, Colombia +3
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Study Endpoints
Primary Endpoints
Vaccine-related Grade 3 or 4 toxicity (other than skin toxicity and influenza-like symptoms) according to the Common Terminology Criteria for Adverse Events version 3.0
During the study.
Objective clinical response (CR or PR)
At each tumor evaluation (Visits 7, 14 and 21)
Secondary Endpoints
Stable disease
At each tumor evaluation (Visits 7, 14 and 21)
Mixed response
At each tumor evaluation (Visits 7, 14 and 21)
Time to disease progression
At the time of analysis.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALPatients receive study vaccinations in 3 consecutive cycles: * In Cycle 1 each patients will receive six vaccinations at two-week intervals followed by evaluation. * In Cycle 2, subjects will patients six vaccinations at two-week intervals followed by evaluation. * In Cycle 3, subjects will patients six vaccinations at three-week intervals.
Group BEXPERIMENTALPatients receive study vaccinations as second-line therapy
Interventions
NameTypeDescription
GSK Biologicals' 719125BIOLOGICALPatients receive six vaccinations at two-week intervals
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites14

Inclusion criteria: * Female. * At least 18 years of age. * Written informed consent to participate in the study. * Diagnosis of advanced breast cancer. Furthermore, for patients being considered for second-line study treatment only: The patient has received a first-line chemotherapy together with ...

Countries:BelgiumColombiaFranceItalyPeru
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