West Cancer Center

ADVANCED SOLID TUMORS: Phase 1; HER2+; \"FS10214100\"

Phase I, two-part, multiple, ascending dose study of the anti-HER2 FCAB FS102 in breast, gastric, and other solid tumors

Title

Bristol-Myers Squibb FS10214100

Study Title

Phase I, two-part, multiple, ascending dose study of the anti-HER2 FCAB FS102 in breast, gastric, and other solid tumors

Site Link

NCT02286219

Malignancy

z- Advanced Solid Tumors, Breast, Gastric, GE junction

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

After failure of all standard therapies

Investigational Agent

FS102

Drug Class

Bi-specific anti-HER2 antibody (Fcab)

Daruka Mahadevan, MD, PhD

Sponsor

Bristol-Myers Squibb

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02286219

Key Eligibility Criteria Details

HER2+ adenocarcinoma (by FISH, regardless of IHC)
Unresectable or metastatic last line
ECOG PS 0-1
Limit of prior cumulative doxorubicin dose of 360mg/m2
No CNS disease
No history of prior cancer within last 3 years
No significant cardiac disease
No HIV, HBV, HCV

Objective

Primary- DLT: Secondary- ORR, PK, safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 positiveadenocarcinoma

Dosing Frequency

Weekly doses escalating from 3mg/kg, 6mg/kg, and 10mg/kg

Control Agents

N/A

Study Protocol

Randomized