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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Interventions

  • Drug: ABT-806
    • ABT-806 will be administered by intravenous infusion.
  • Drug: ABT-806i
    • ABT-806i will be administered by intravenous infusion.

Arms, Groups and Cohorts

  • Experimental: ABT-806 Arm
    • Subjects with advanced solid tumors
  • Experimental: ABT-806i Arm
    • Subjects with advanced solid tumors

Clinical Trial Outcome Measures

Primary Measures

  • Single-Photon Emission Computerized Tomography (SPECT)
    • Time Frame: Week 1
    • Tumor receptor occupancy (Cohort 1 and Cohort 2)
  • Single-Photon Emission Computerized Tomography (SPECT)
    • Time Frame: Week 6
    • Tumor receptor occupancy (Cohort 2)
  • Whole body planar imaging
    • Time Frame: Week 1
    • Biodistribution and dosimetry (Cohort 1 and Cohort 2)
  • Whole body planar imaging
    • Time Frame: Week 6
    • Biodistribution and dosimetry (Cohort 2)

Secondary Measures

  • Pharmacokinetic profile evaluation – Cohort 1
    • Time Frame: From Day 1 through Final Visit
    • Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
  • Pharmacokinetic profile evaluation – Cohort 2
    • Time Frame: From Day 1 through Final Visit
    • Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
  • Single-Photon Emission Computerized Tomography (SPECT)
    • Time Frame: Week 1
    • ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression – Cohort 2
  • Single-Photon Emission Computerized Tomography (SPECT)
    • Time Frame: Week 6
    • ABT-806i uptake correlation with EGFR vIII expression – Cohort 2
  • Whole body planar imaging
    • Time Frame: Week 1
    • ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression – Cohort 2
  • Whole body planar imaging
    • Time Frame: Week 6
    • ABT-806i uptake correlation with EGFR vIII expression – Cohort 2
  • Blood pressure – Cohort 1
    • Time Frame: Screening through Week 2
  • Heart rate – Cohort 1
    • Time Frame: Screening through Week 2
  • Body temperature – Cohort 1
    • Time Frame: Screening through Week 2
  • Number of subjects with Adverse Events – Cohort 1
    • Time Frame: Day 1 Through Week 2
    • The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
  • Chemistry – Cohort 1
    • Time Frame: Sceening, Week 1 and Final Visit
  • Hematology – Cohort 1
    • Time Frame: Sceening, Week 1 and Final Visit
  • Urinalysis – Cohort 1
    • Time Frame: Sceening, Week 1 and Final Visit
  • Physical Examination – Cohort 1
    • Time Frame: Screening, Week 1 and Final Visit
    • Physical exam including body weight will be performed.
  • Electrocardiogram (ECG) – Cohort 1
    • Time Frame: Baseline and Final Visit
    • 12-lead ECG will be performed.
  • Heart rate – Cohort 2
    • Time Frame: Screening Through Week 8
  • Blood pressure – Cohort 2
    • Time Frame: Screening Through Week 8
  • Number of subjects with Adverse Events – Cohort 2
    • Time Frame: Day 1 Through Week 8
    • The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
  • Body temperature – Cohort 2
    • Time Frame: Screening Through Week 8
  • Hematology – Cohort 2
    • Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
  • Chemistry – Cohort 2
    • Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
  • Physical Examination – Cohort 2
    • Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
    • Physical exam including body weight will be performed.
  • Urinalysis – Cohort 2
    • Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit
  • Electrocardiogram (ECG) – Cohort 2
    • Time Frame: Baseline and Week 6
    • 12-lead ECG will be performed.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie (prior sponsor, Abbott)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kyle D. Holen, MD, Study Director, AbbVie

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