The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of GBR 1302 monotherapy in subjects with HER2 positive cancers
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Increasing doses, IV on day 1 and 15 of each 28 day cycle
Glenmark Investigational Site 204
Fairway, Kansas, United States
Glenmark Investigational Site 209
Detroit, Michigan, United States
Glenmark Investigational Site 201
Dallas, Texas, United States
Glenmark Investigational Site 203
Salt Lake City, Utah, United States
Maximal Tolerated Dose (MTD) of GBR 1302
Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort
Time frame: 28 Days
The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03
Time frame: 28 Days
Objective Response Rate (ORR) for solid tumors.
Time frame: 2 cycles, 56 days
Disease control rate (DCR) for solid tumors
Time frame: 2 cycles, 56 days
Duration of disease control (measured from drug start date to the date of disease progression or death for subjects who had CR or PR or SD during treatment).
Time frame: At least 56 days
Maximum Concentration (Cmax) of GBR 1302
Time frame: 28 Days
Time to Maximum Concentration (Tmax) of GBR 1302
Time frame: 28 Days
Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302
Time frame: 28 Days
Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline
Time frame: 28 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Glenmark Investigational Site 103
Berlin, Germany
Glenmark Investigational Site 102
Cologne, Germany
Glenmark Investigational Site 101
Dresden, Germany
Glenmark Investigational Site 104
Mainz, Germany