First-in-human Study of AB0024 to Evaluate Safety and Tolerability in Adults With Advanced Solid Tumors

Neoplasms Clinical Trial

Official title: A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Advanced Solid Tumors

Status Completed

Clinical Trial Summary

Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024.

Clinical Trial Description

This is a first-in-human, open-label, sequential dose escalation study to evaluate AB0024 in patients with advanced solid tumors. The study will consist of two parts: Part A will be a dose escalation, and Part B will be a dose expansion.The primary objective of this study is to characterize the safety, tolerability, and PK of AB0024 after multiple IV administrations in patients with advanced solid tumors. The secondary objectives are to measure the tumor response by modified RECIST and to evaluate the formation of anti-AB0024 antibodies.

Patients will receive infusions of AB0024 every two weeks. Patients will be seen weekly for safety assessments and collection of blood samples. Patients who do not show evidence of disease progression by clinical assessment or by CT or MRI may continue receiving AB0024 every 2 weeks until disease progression (clinical or radiographic), study drug intolerance, or withdrawal of consent. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT01323933
• Study type: Interventional
• Source: Gilead Sciences
• Status: Completed
• Phase: Phase 1
• Start date: June 2010
• Completion date: March 2012