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

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)

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: ABT-806; Drug: ABT-806i

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Heidelberg, Australia, 3084
    • Site Reference ID/Investigator# 52203
  • Herston, Australia, 4029
    • Site Reference ID/Investigator# 58242

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABT-806 Arm; Subjects with advanced solid tumors	Drug: ABT-806; ABT-806 will be administered by intravenous infusion.
Experimental: ABT-806i Arm; Subjects with advanced solid tumors	Drug: ABT-806i; ABT-806i will be administered by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Investigators: Study Director: Kyle D. Holen, MD, AbbVie

Publications and helpful links

General Publications

• Gan HK, Burge M, Solomon B, Lee ST, Holen KD, Zhang Y, Ciprotti M, Lee FT, Munasinghe W, Fischer J, Ansell P, Fox G, Xiong H, Reilly EB, Humerickhouse R, Scott AM. A Phase 1 and Biodistribution Study of ABT-806i, an 111In-Radiolabeled Conjugate of the Tumor-Specific Anti-EGFR Antibody ABT-806. J Nucl Med. 2021 Jun 1;62(6):787-794. doi: 10.2967/jnumed.120.253146. Epub 2021 Jan 28.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: November 11, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): January 14, 2013
• Last Update Submitted That Met QC Criteria: January 10, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: M11-849