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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-806 Arm | Experimental | Subjects with advanced solid tumors |
|
| ABT-806i Arm | Experimental | Subjects with advanced solid tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-806 | Drug | ABT-806 will be administered by intravenous infusion. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle D. Holen, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 52203 | Heidelberg | 3084 | Australia | |||
| Site Reference ID/Investigator# 58242 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33509972 | Derived | 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. |
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| ABT-806i |
| Drug |
ABT-806i will be administered by intravenous infusion. |
|
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 |
| Herston |
| 4029 |
| Australia |
| ID | Term |
|---|---|
| C000604456 | depatuxizumab |
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