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FS102

Phase 1

Solid Tumors That Overexpress HER2 (HER2 Positive) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 18, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02286219Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors (Anti HER2 Fcab)PHASE1 COMPLETED 30 — — Nov 4, 2014Jun 8, 2017Sep 18, 20176 United States, Canada
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Study Endpoints
Primary Endpoints
Adverse events as assessed by NCI Common Toxicity Criteria for Adverse Events CTCAE v3.0
1 year
Secondary Endpoints
Clinical benefit as assessed by objective response rate
1 year
PK profile as assessed by drug levels
1 year
Adverse events as assessed by immune response to drug
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FS102EXPERIMENTALDose escalation of either weekly or Q3W of FS102
Interventions
NameTypeDescription
FS102DRUGExperimental
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 1. Signed written informed consent obtained prior to performing any study procedure, including screening procedures. 2. Men and women ≥ 18-years-old on the day of signing infor...

Countries:United StatesCanada
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