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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: ABT-806
* Drug: ABT-806i


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |