An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Single-Photon Emission Computerized Tomography (SPECT) [Week 1]
Tumor receptor occupancy (Cohort 1 and Cohort 2)
- Single-Photon Emission Computerized Tomography (SPECT) [Week 6]
Tumor receptor occupancy (Cohort 2)
- Whole body planar imaging [Week 1]
Biodistribution and dosimetry (Cohort 1 and Cohort 2)
- Whole body planar imaging [Week 6]
Biodistribution and dosimetry (Cohort 2)
Secondary Outcome Measures
- 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 1]
ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
- Single-Photon Emission Computerized Tomography (SPECT) [Week 6]
ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
- Whole body planar imaging [Week 1]
ABT-806i uptake correlation with Epidermal Growth Factor Receptor (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]
- 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.
- 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 [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 52203 | Heidelberg | Australia | 3084 | |
| 2 | Site Reference ID/Investigator# 58242 | Herston | Australia | 4029 |
Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: Kyle D. Holen, MD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M11-849