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Immunotherapeutic SB719125

Phase 1

Neoplasms, Breast | Monoclonal antibody | Oncology |GSK plc|Last Updated: May 15, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

Immunotherapeutic SB719125 · 1 trial · 1 indication

Phase 1 1
NCT00058526A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast CancerNeoplasms, Breast
COMPLETED61 Analytics
PHASE1COMPLETED
A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast Cancer
Neoplasms, Breast
NCT0005852661
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Study Endpoints

Primary Endpoints

Occurrence of dose limiting toxicity (DLT)
During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of cardiotoxicity
During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of Grade 3 or 4 adverse events
During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of solicited local and general signs and symptoms recorded by the patient on diary cards
Period of eight days (Day 0 to Day 7) immediately after each administration of the study treatment
Occurrence of unsolicited non-serious adverse events
During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Occurrence of serious adverse events
During the study period (until Week 40 or 43) and the post-study follow-up period (5 years)
Hematological, biochemical (including auto-immunity) and urinalysis parameters
During the study period (until Week 40 or 43)
Changes in vital signs
During the entire study period (until Week 40 or 43)
Physical examination findings
During the study period (until Week 40 or 43)

Secondary Endpoints

Anti-dHER2, anti-HER2 ECD (extracellular domain), anti-HER2 ICD (intracellular domain) antibody concentrations
Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period
Anti-dHER2, anti-HER2 ECD and anti-HER2 ICD seropositivity
Two weeks after the fourth and sixth study treatment administrations (Week 6 and Week 14) and at the three and six months follow-up visit (Week 26 and Week 40). At yearly visits during the five-year follow-up period
In vitro functional activity response (e.g. growth inhibition of HER2-overexpressing breast tumor cells) expressed as a percentage of inhibition
After four or six administrations of the study treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSix doses of dHER2 (20 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14.
Cohort 2EXPERIMENTALSix doses of dHER2 (100 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14.
Cohort 3EXPERIMENTALSix doses of dHER2 (500 µg) + AS15 administered at Weeks 0, 2, 4, 6, 10 and 14. Patients in this cohort can receive two booster doses at Weeks 34 and 38, respectively.
Cohort 4EXPERIMENTALThree doses of dHER2 (20 µg) + AS15 administered at Weeks 0, 4, and 14. Patients in this cohort can receive two booster doses at Weeks 34 and 38, respectively.

Interventions

NameTypeDescription
Immunotherapeutic SB719125 (Primary)BIOLOGICALIntramuscular injection
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Eligibility Criteria

Age Range40 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites17

Inclusion criteria: 1. Patient must have a previous diagnosis of HER2/neu-positive breast cancer: FISH positive test (for HercepTest 2+ patients), or, HercepTest 3+ patients. 2. Patients must be Stage II with at least one positive node or Stage III in remission. Patients must have had standard trea...

Countries:United StatesAustraliaBelgiumFranceItaly
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Frequently asked questions about Immunotherapeutic SB719125

What is Immunotherapeutic SB719125 used for?

Immunotherapeutic SB719125 is an investigational monoclonal antibody being studied for use in neoplasms, specifically breast cancer. It is being evaluated in patients with HER2-overexpressing, high-risk breast cancer. The drug is currently in Phase 1 clinical development and is not approved for any indication.

What does Immunotherapeutic SB719125 target?

Immunotherapeutic SB719125 is a monoclonal antibody that targets HER2, as indicated by its clinical trial in HER2-overexpressing breast cancer patients. It is designed to address high-risk breast cancer by interacting with the HER2 receptor, which is overexpressed in certain breast tumors.

Who makes Immunotherapeutic SB719125?

Immunotherapeutic SB719125 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical research on this investigational monoclonal antibody for the treatment of breast cancer.

What phase is Immunotherapeutic SB719125 in?

Immunotherapeutic SB719125 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for its safety and efficacy in breast cancer.

What clinical trials is Immunotherapeutic SB719125 in?

Immunotherapeutic SB719125 has one completed clinical trial, identified as NCT00058526. This was a Phase 1 dose-escalation vaccine trial in HER2-overexpressing patients with high-risk breast cancer. The trial enrolled 61 female participants aged 40 years and older across the United States, Australia, Belgium, France, and Italy.

Is Immunotherapeutic SB719125 the same as a vaccine?

Immunotherapeutic SB719125 is a monoclonal antibody, but its Phase 1 trial was described as a dose-escalation vaccine trial. The study, NCT00058526, evaluated the drug in HER2-overexpressing breast cancer patients, suggesting it may have immunotherapeutic properties. However, the drug is classified as a monoclonal antibody modality.