Clinical trial NCT01472003: An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Single-Photon Emission Computerized Tomography (SPECT)
timeFrame: Week 1
measure: Single-Photon Emission Computerized Tomography (SPECT)
timeFrame: Week 6
measure: Whole body planar imaging
timeFrame: Week 1
measure: Whole body planar imaging
timeFrame: Week 6
Secondary outcomes:
measure: Pharmacokinetic profile evaluation - Cohort 1
timeFrame: From Day 1 through Final Visit
measure: Pharmacokinetic profile evaluation - Cohort 2
timeFrame: From Day 1 through Final Visit
measure: Single-Photon Emission Computerized Tomography (SPECT)
timeFrame: Week 1
measure: Single-Photon Emission Computerized Tomography (SPECT)
timeFrame: Week 6
measure: Whole body planar imaging
timeFrame: Week 1
measure: Whole body planar imaging
timeFrame: Week 6
measure: Blood pressure - Cohort 1
timeFrame: Screening through Week 2
measure: Heart rate - Cohort 1
timeFrame: Screening through Week 2
measure: Body temperature - Cohort 1
timeFrame: Screening through Week 2
measure: Number of subjects with Adverse Events - Cohort 1
timeFrame: Day 1 Through Week 2
measure: Chemistry - Cohort 1
timeFrame: Sceening, Week 1 and Final Visit
measure: Hematology - Cohort 1
timeFrame: Sceening, Week 1 and Final Visit
measure: Urinalysis - Cohort 1
timeFrame: Sceening, Week 1 and Final Visit
measure: Physical Examination - Cohort 1
timeFrame: Screening, Week 1 and Final Visit
measure: Electrocardiogram (ECG) - Cohort 1
timeFrame: Baseline and Final Visit
measure: Heart rate - Cohort 2
timeFrame: Screening Through Week 8
measure: Blood pressure - Cohort 2
timeFrame: Screening Through Week 8
measure: Number of subjects with Adverse Events - Cohort 2
timeFrame: Day 1 Through Week 8
measure: Body temperature - Cohort 2
timeFrame: Screening Through Week 8
measure: Hematology - Cohort 2
timeFrame: Screening, Week 1, 2, 4, 6, and Final Visit
measure: Chemistry - Cohort 2
timeFrame: Screening, Week 1, 2, 4, 6, and Final Visit
measure: Physical Examination - Cohort 2
timeFrame: Screening, Week 1, 2, 4, 6, and Final Visit
measure: Urinalysis - Cohort 2
timeFrame: Screening, Week 1, 2, 4, 6, and Final Visit
measure: Electrocardiogram (ECG) - Cohort 2
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Site Reference ID/Investigator# 52203
city: Herston
country: Australia
facility: Site Reference ID/Investigator# 58242
Study officials:
affiliation: AbbVie
name: Kyle D. Holen, MD
role: STUDY_DIRECTOR
References:
citation: 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.