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Brief Title: Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors
Official Title: A Phase I, First Time in Human, Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Anti-Her3 Monoclonal Antibody GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors
Study ID: NCT01966445
Brief Summary: Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3. This study is a phase I, first time in human, open-label, dose escalation study. The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended dose regimen and also to evaluate preliminary evidence of clinical benefit.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Aurora, Colorado, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Salt Lake City, Utah, United States
GSK Investigational Site, Heidelberg, Victoria, Australia
GSK Investigational Site, Melbourne, Victoria, Australia
GSK Investigational Site, Nedlands, Western Australia, Australia
GSK Investigational Site, Amsterdam, , Netherlands
GSK Investigational Site, Amsterdam, , Netherlands
GSK Investigational Site, Groningen, , Netherlands
GSK Investigational Site, Groningen, , Netherlands
GSK Investigational Site, Nijmegen, , Netherlands
GSK Investigational Site, Nijmegen, , Netherlands
GSK Investigational Site, Rotterdam, , Netherlands
GSK Investigational Site, Rotterdam, , Netherlands
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Role: STUDY_DIRECTOR