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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

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

FS102 · 1 trial · 1 indication

Phase 1 1
NCT02286219Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors (Anti HER2 Fcab)Solid Tumors That Overexpress HER2 (HER2 Positive)
COMPLETED30 Analytics
PHASE1COMPLETED
Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors (Anti HER2 Fcab)
Solid Tumors That Overexpress HER2 (HER2 Positive)Unlock trial analytics

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 to 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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Frequently asked questions about FS102

What is FS102 used for?

FS102 is an investigational small molecule being studied for the treatment of solid tumors that overexpress HER2, also known as HER2 positive solid tumors. It is currently in Phase 1 clinical development and is not yet approved by the FDA.

What does FS102 target?

FS102 targets HER2, a protein that is overexpressed in certain solid tumors. By targeting HER2, FS102 is designed to interfere with the signaling pathways that drive tumor growth in HER2 positive cancers.

Who makes FS102?

FS102 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY.

What phase is FS102 in?

FS102 is in Phase 1 clinical development. A Phase 1 multiple ascending dose study has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities.

What clinical trials is FS102 in?

FS102 has one completed clinical trial, identified as NCT02286219. This was a Phase 1, multiple ascending dose study of anti-HER2 FCAB FS102 in HER2 positive solid tumors, conducted in the United States and Canada with 30 participants.

Is FS102 the same as anti-HER2 FCAB?

Yes, FS102 is also referred to as anti-HER2 FCAB in clinical trial documentation. The completed study NCT02286219 is titled 'Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors'.