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

AbbVie

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: ABT-806i

Drug: ABT-806

Study type

Interventional

Funder types

Industry

Identifiers

NCT01472003

M11-849

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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