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Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors

ABSTRACT: 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.

DISEASE(S): Cervical Cancer,Melanoma,Colorectal Cancer,Bladder Cancer,Subjects With Advanced Her3-positive Solid Tumors,Breast Cancer,Neoplasms,Ovarian Cancer,Pancreas Cancer,Gastric Cancer,Non-small Cell Lung Cancer,Prostate Cancer,Head And Neck Cancer,Hepatocellular Carcinoma,Cancer

PROVIDER: 2153438 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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