An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label study designed to evaluate the biodistribution and imaging characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Criteria

Inclusion Criteria:

• Subject has a solid tumor of a type likely or known to either overexpress wild-type Epidermal Growth Factor Receptor (EGFR) or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, Non-small Cell Lung Carcinoma (NSCLC), and colorectal carcinoma).

• Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.

• Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.

• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

• Subject must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with at least 1 extrahepatic 2 cm lesion.

Exclusion Criteria:

• Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 14 days prior to the first dose of ABT-806i.

• Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806i.

• Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.

• Subject has had major surgery within 21 days prior to the first dose of ABT-806i.

• Subject has a clinically significant uncontrolled condition(s) including but not limited to the following:

• Active uncontrolled infection

• Symptomatic congestive heart failure

• Unstable angina pectoris or cardiac arrhythmia

• Psychiatric illness/social situation that would limit compliance with the study requirements