An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types

NCT ID: NCT01472003

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ABT-806 Arm

Subjects with advanced solid tumors

Group Type: EXPERIMENTAL

ABT-806

Intervention Type: DRUG

ABT-806 will be administered by intravenous infusion.

ABT-806i Arm

Subjects with advanced solid tumors

Group Type: EXPERIMENTAL

ABT-806i

Intervention Type: DRUG

ABT-806i will be administered by intravenous infusion.

Interventions

ABT-806

ABT-806 will be administered by intravenous infusion.

Intervention Type: DRUG

ABT-806i

ABT-806i will be administered by intravenous infusion.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle D. Holen, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 52203

Heidelberg, , Australia

Site Reference ID/Investigator# 58242

Herston, , Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 33509972 (View on PubMed)

Other Identifiers

M11-849

Identifier Type: -

Identifier Source: org_study_id