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FS102

Phase 1

Solid Tumors That Overexpress HER2 (HER2 Positive) | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Sep 18, 2017

FS102 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

FS102 clinical trials

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?

FS102 is an investigational small molecule developed by Bristol-Myers Squibb for solid tumors that overexpress HER2, also called HER2 positive tumors. It was evaluated in a single Phase 1 clinical trial and is not an approved therapy.

What is FS102 used for in HER2 positive solid tumors?

FS102 was studied for the treatment of solid tumors that overexpress HER2, meaning HER2 positive cancers. The Phase 1 trial enrolled adults with these HER2 positive solid tumors. FS102 is investigational and has not been approved for any use.

Who makes FS102?

FS102 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of FS102 in HER2 positive solid tumors.

What phase is FS102 in?

FS102 is in Phase 1 development. It has completed one Phase 1 trial, and no later-stage trials have been recorded. FS102 is investigational and is not FDA approved.

What clinical trials is FS102 in?

FS102 was studied in one Phase 1 trial, NCT02286219, titled a Phase 1, Multiple Ascending Dose Study of Anti-HER2 FCAB FS102 in HER2 Positive Solid Tumors. The trial enrolled 30 participants across the United States and Canada and is completed.

Was the FS102 trial randomized or blinded?

The FS102 Phase 1 trial, NCT02286219, was an uncontrolled, non-randomized, open-label study, so participants were not assigned by chance and neither participants nor investigators were blinded to treatment. It enrolled 30 adults aged 18 years and older with HER2 positive solid tumors.