Advanced Solid Tumors
Conditions
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.
Interventions
DRUGABT-806
ABT-806 will be administered by intravenous infusion.
DRUGABT-806i
ABT-806i will be administered by intravenous infusion.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single-Photon Emission Computerized Tomography (SPECT) | Week 1 | Tumor receptor occupancy (Cohort 1 and Cohort 2) |
| Whole body planar imaging | Week 1 | Biodistribution and dosimetry (Cohort 1 and Cohort 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Whole body planar imaging | Week 1 | ABT-806i uptake correlation with Epidermal Growth Factor Receptor (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 | — |
| Chemistry - Cohort 2 | Screening, Week 1, 2, 4, 6, and Final Visit | — |
| 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 | — |
| 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. |
| Physical Examination - Cohort 1 | Screening, Week 1 and Final Visit | Physical exam including body weight will be performed. |
| 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 |
Countries
Australia
Outcome results
None listed