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Advanced Solid TumorsPhase 1NCT01472003

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

A Phase 1 study testing ABT-806 and ABT-806i in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ABT-806 and ABT-806i
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesAustralia
Study dates
Oct 2011to Dec 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia
  • Psychiatric illness/social situation that would limit compliance with the study requirements

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Site Reference ID/Investigator# 52203

    Heidelberg, 3084

  • Site Reference ID/Investigator# 58242

    Herston, 4029

Other trials in Australia

About this study

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)

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.

Being tested
ABT-806, ABT-806i

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-806Drug

    ABT-806 will be administered by intravenous infusion.

  • ABT-806iDrug

    ABT-806i will be administered by intravenous infusion.

Study groups in NCT01472003
Study groupRoleWhat they receive
ABT-806 ArmExperimentalSubjects with advanced solid tumors
Receives: Drug: ABT-806
ABT-806i ArmExperimentalSubjects with advanced solid tumors
Receives: Drug: ABT-806i

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Single-Photon Emission Computerized Tomography (SPECT)

    Tumor receptor occupancy (Cohort 1 and Cohort 2)

    Measured: Week 1

  2. Single-Photon Emission Computerized Tomography (SPECT)

    Tumor receptor occupancy (Cohort 2)

    Measured: Week 6

  3. Whole body planar imaging

    Biodistribution and dosimetry (Cohort 1 and Cohort 2)

    Measured: Week 1

  4. Whole body planar imaging

    Biodistribution and dosimetry (Cohort 2)

    Measured: Week 6

Secondary outcomes (24)

  1. Pharmacokinetic profile evaluation - Cohort 1

    Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints

    Measured: From Day 1 through Final Visit

  2. Pharmacokinetic profile evaluation - Cohort 2

    Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints

    Measured: From Day 1 through Final Visit

  3. Single-Photon Emission Computerized Tomography (SPECT)

    ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2

    Measured: Week 1

  4. Single-Photon Emission Computerized Tomography (SPECT)

    ABT-806i uptake correlation with EGFR vIII expression - Cohort 2

    Measured: Week 6

  5. Whole body planar imaging

    ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2

    Measured: Week 1

  6. Whole body planar imaging

    ABT-806i uptake correlation with EGFR vIII expression - Cohort 2

    Measured: Week 6

  7. Blood pressure - Cohort 1

    Measured: Screening through Week 2

  8. Heart rate - Cohort 1

    Measured: Screening through Week 2

  9. Body temperature - Cohort 1

    Measured: Screening through Week 2

  10. Number of subjects with Adverse Events - Cohort 1

    The investigator will monitor each subject for clinical and laboratory evidence of adverse events.

    Measured: Day 1 Through Week 2

  11. Chemistry - Cohort 1

    Measured: Sceening, Week 1 and Final Visit

  12. Hematology - Cohort 1

    Measured: Sceening, Week 1 and Final Visit

  13. Urinalysis - Cohort 1

    Measured: Sceening, Week 1 and Final Visit

  14. Physical Examination - Cohort 1

    Physical exam including body weight will be performed.

    Measured: Screening, Week 1 and Final Visit

  15. Electrocardiogram (ECG) - Cohort 1

    12-lead ECG will be performed.

    Measured: Baseline and Final Visit

  16. Heart rate - Cohort 2

    Measured: Screening Through Week 8

  17. Blood pressure - Cohort 2

    Measured: Screening Through Week 8

  18. Number of subjects with Adverse Events - Cohort 2

    The investigator will monitor each subject for clinical and laboratory evidence of adverse events.

    Measured: Day 1 Through Week 8

  19. Body temperature - Cohort 2

    Measured: Screening Through Week 8

  20. Hematology - Cohort 2

    Measured: Screening, Week 1, 2, 4, 6, and Final Visit

  21. Chemistry - Cohort 2

    Measured: Screening, Week 1, 2, 4, 6, and Final Visit

  22. Physical Examination - Cohort 2

    Physical exam including body weight will be performed.

    Measured: Screening, Week 1, 2, 4, 6, and Final Visit

  23. Urinalysis - Cohort 2

    Measured: Screening, Week 1, 2, 4, 6, and Final Visit

  24. Electrocardiogram (ECG) - Cohort 2

    12-lead ECG will be performed.

    Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472003
Sponsor's protocol ID
M11-849
Status last verified
Jan 2013
First submitted
12 Oct 2011
Last updated
14 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33509972

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-806 and ABT-806i in people with Advanced Solid Tumors, run by AbbVie (prior sponsor, Abbott) at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single-Photon Emission Computerized Tomography (SPECT) (time frame: Week 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01472003, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.

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