An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types
- Registration Number
- NCT01472003
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
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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.
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Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806i.
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Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
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Subject has had major surgery within 21 days prior to the first dose of ABT-806i.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABT-806 Arm ABT-806 Subjects with advanced solid tumors ABT-806i Arm ABT-806i Subjects with advanced solid tumors
- Primary Outcome Measures
Name Time Method Single-Photon Emission Computerized Tomography (SPECT) Week 6 Tumor receptor occupancy (Cohort 2)
Whole body planar imaging Week 6 Biodistribution and dosimetry (Cohort 2)
- Secondary Outcome Measures
Name Time Method Hematology - Cohort 1 Sceening, Week 1 and Final Visit Urinalysis - Cohort 1 Sceening, Week 1 and Final Visit Pharmacokinetic profile evaluation - Cohort 1 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 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) Week 6 ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
Whole body planar imaging Week 6 ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
Blood pressure - Cohort 1 Screening through Week 2 Chemistry - Cohort 1 Sceening, Week 1 and Final Visit Heart rate - Cohort 1 Screening through Week 2 Body temperature - Cohort 1 Screening through Week 2 Number of subjects with Adverse Events - Cohort 1 Day 1 Through Week 2 The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
Physical Examination - Cohort 1 Screening, Week 1 and Final Visit Physical exam including body weight will be performed.
Electrocardiogram (ECG) - Cohort 1 Baseline and Final Visit 12-lead ECG will be performed.
Heart rate - Cohort 2 Screening Through Week 8 Blood pressure - Cohort 2 Screening Through Week 8 Number of subjects with Adverse Events - Cohort 2 Day 1 Through Week 8 The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
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 Screening, Week 1, 2, 4, 6, and Final Visit Physical exam including body weight will be performed.
Urinalysis - Cohort 2 Screening, Week 1, 2, 4, 6, and Final Visit Electrocardiogram (ECG) - Cohort 2 Baseline and Week 6 12-lead ECG will be performed.
Trial Locations
- Locations (2)
Site Reference ID/Investigator# 52203
🇦🇺Heidelberg, Australia
Site Reference ID/Investigator# 58242
🇦🇺Herston, Australia