Advanced Solid Tumors
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects with advanced solid tumors and to determine a phase 2 dose.
Interventions
DRUGHGS1029
Escalating doses by IV (in the vein), on days 1, 8 and 15 of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed advanced solid malignancy * Life expectancy of at least 3 months * Age 18 years or older * Acceptable liver function * Acceptable renal function * Acceptable hematologic status
Exclusion criteria
* Received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment. * Received non-investigational agent within 3 weeks before enrollment. * Progressive CNS involvement including the need of corticosteroids * Pregnant or breast-feeding women * Active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of Cycle 1 Day 1 * Known HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity | throughout the study |
Countries
United States
Outcome results
None listed