A Study of HGS1029 (AEG40826-2HCl) in Subjects With Advanced Solid Tumors

Human Genome Sciences

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: HGS1029

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708006

HGS1029-C1078

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

1

Experimental group

Description:

HGS1029

Treatment:

Drug: HGS1029