An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types Likely to Express Epidermal Growth Factor Receptor (EGFR)
- 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
- 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
- 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.
- 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