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GSK Biologicals' 719125

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' 719125 · 1 trial · 1 indication

Phase 1 1
NCT00140738Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast CancerNeoplasms, Breast
COMPLETED3 Analytics
PHASE1COMPLETED
Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer
Neoplasms, Breast
NCT001407383
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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 to 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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Frequently asked questions about GSK Biologicals' 719125

What is GSK Biologicals' 719125 used for?

GSK Biologicals' 719125 is an investigational monoclonal antibody being developed for the treatment of breast neoplasms, specifically HER2-positive metastatic breast cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes GSK Biologicals' 719125?

GSK Biologicals' 719125 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The drug is an investigational monoclonal antibody in Phase 1 clinical development for breast cancer.

What phase is GSK Biologicals' 719125 in?

GSK Biologicals' 719125 is in Phase 1 clinical development. It is an investigational monoclonal antibody being studied for the treatment of HER2-positive metastatic breast cancer. The drug has not been approved and remains in early-stage clinical testing.

What clinical trials is GSK Biologicals' 719125 in?

GSK Biologicals' 719125 has been studied in one completed Phase 1 clinical trial, identified as NCT00140738. This trial assessed the safety and immunogenicity of the drug in patients with HER2-positive metastatic breast cancer and enrolled 3 female participants aged 18 years and older.

Is GSK Biologicals' 719125 the same as dHER2 vaccine?

GSK Biologicals' 719125 is associated with a vaccine approach, as the clinical trial NCT00140738 evaluated a new dHER2 vaccine for HER2-positive metastatic breast cancer. The drug is a monoclonal antibody modality, and the trial title refers to it as a vaccine, indicating it may be an immunotherapeutic agent.