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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Single-Photon Emission Computerized Tomography (SPECT)

Outcome Description:

Tumor receptor occupancy (Cohort 1 and Cohort 2)

Outcome Time Frame:

Week 1

Safety Issue:

No

Principal Investigator

Kyle D. Holen, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

M11-849

NCT ID:

NCT01472003

Start Date:

October 2011

Completion Date:

December 2012

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

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