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Immunotherapeutic SB719125

Phase 1

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

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 Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00058526A Dose-escalation Vaccine Trial in HER2-overexpressing Patients With High-risk Breast CancerPHASE1 COMPLETED 61 — — Mar 20, 2003Sep 6, 2006May 15, 201717 United States, Australia +3
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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 — 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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