NCT01472003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

October 12, 2011

Last Update Submit

January 10, 2013

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (24)

  • Pharmacokinetic profile evaluation - Cohort 1

    From Day 1 through Final Visit

  • Pharmacokinetic profile evaluation - Cohort 2

    From Day 1 through Final Visit

  • Single-Photon Emission Computerized Tomography (SPECT)

    Week 1

  • Single-Photon Emission Computerized Tomography (SPECT)

    Week 6

  • Whole body planar imaging

    Week 1

  • +19 more secondary outcomes

Study Arms (2)

ABT-806 Arm

EXPERIMENTAL

Subjects with advanced solid tumors

Drug: ABT-806

ABT-806i Arm

EXPERIMENTAL

Subjects with advanced solid tumors

Drug: ABT-806i

Interventions

ABT-806DRUG

ABT-806 will be administered by intravenous infusion.

ABT-806 Arm
ABT-806iDRUG

ABT-806i will be administered by intravenous infusion.

ABT-806i Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site Reference ID/Investigator# 52203

Heidelberg, 3084, Australia

Location

Site Reference ID/Investigator# 58242

Herston, 4029, Australia

Location

Related Publications (1)

  • 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.

    PMID: 33509972DERIVED

MeSH Terms

Interventions

depatuxizumab

Study Officials

  • Kyle D. Holen, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2011

First Posted

November 16, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

AU(2)