89Zr-AMG211 PET Imaging Study

June 1, 2017 updated by: Prof.dr. E.G.E. de Vries, University Medical Center Groningen

89Zr-AMG211 PET Imaging in Patients With Relapsed/Refractory Gastrointestinal Adenocarcinoma Before and During Treatment With AMG 211

AMG 211 is a bispecific single-chain antibody construct of the bispecific T-cell engager (BiTE®) class that targets human carcinoembryonic antigen (CEA, CD66e) on (tumor) cells and cluster of differentiation 3 (CD3) positive T-cells. AMG 211 is a potentially new targeted drug in the treatment of relapsed/refractory gastrointestinal adenocarcinoma, since those are CEA expressing tumors. A well-known challenge in current drug development using targeted therapies is the high level of heterogeneity of target expression that is present in specific tumor types. Radio-labeling of AMG 211 with the positron emission tomography (PET) radionuclide Zirconium-89 (89Zr) enables non-invasive imaging and quantification of AMG 211 distribution in cancer patients. By performing a 89Zr-AMG211 PET scan prior to treatment with AMG 211, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated. By performing a 89Zr-AMG211 PET scan during AMG 211 continuous intravenous (cIV) treatment the investigators will be able to evaluate the impact of prolonged steady state exposure of AMG 211 on tumor and tissue uptake. The 89Zr-AMG211 PET imaging study may help to identify patients more likely to benefit from AMG 211 therapy.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amsterdam, Netherlands, 1081 HV
        • VUMC
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject will or is also participating in the ongoing phase 1 study in which AMG 211 is administered via cIV. 89Zr-AMG211 PET imaging will be performed before and/or during treatment with AMG 211 cIV
  • Informed consent provided
  • Male or Female ≥ 18 years of age at the time of informed consent
  • Advanced relapsed/refractory gastrointestinal adenocarcinoma
  • At least 1 measurable tumor lesion

    o In case the investigators do not find any uptake in metastatic liver lesions in the first set of patients on the 89Zr-AMG211 PET scan, than subsequent patients need to have at least 1 measurable tumor lesion outside the liver

  • Archival tumor tissue available or is willing to undergo biopsy of a tumor lesion before the start of treatment
  • Adequate hematological, renal, and liver function
  • Body weight ≥ 45 kg
  • Other inclusion criteria may apply

Exclusion Criteria:

  • Malignancy other than GI adenocarcinoma requiring current therapy
  • Evidence of uncontrolled systemic disease (other than GI adenocarcinoma), active infection, Hepatitis B and/or C, HIV, history of cardiac disease, history of significant central nervous system (CNS) disease, history of chronic autoimmune disease (with the exception of stable type 1 diabetes)
  • Major surgery within 28 days of study day 1
  • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded.

    o Exception to this criterion is the participation in the currently ongoing phase 1 study with AMG 211 cIV and all procedures related to this study.

  • Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer within 14 days prior to study entry or not recovered from treatment
  • Unresolved toxicities from prior anti-tumor therapy
  • Males or Females of reproductive potential and unwilling to practice an acceptable method of effective birth control while on study through 30 days after receiving the last dose of study drug.
  • Females who are pregnant, planning to become pregnant, lactating/breastfeeding or who plan to breastfeed while on study through 30 days after receiving the last dose of study drug
  • Other exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 89Zr-AMG211 and 89Zr-AMG211 PET
Injection of 89Zr-AMG211 for imaging.
89Zr-AMG211 PET scan(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The quantitative uptake op 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Response to AMG 211 therapy according to the immune related response criteria (irRC) will be correlated to 89Zr-AMG211 tumor uptake data (measured in SUV).
Time Frame: 1 year
1 year
Number of patients with adverse events after 89Zr-AMG211 injection as a measure of safety and tolerability. Incidence, nature and severity of adverse events (according to CTCAE version 4.03) will be measured.
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Explore the target tissue saturation by AMG 211, defined as changes in tissue uptake of radioactivity concentration, and correlate it with pharmacokinetics.
Time Frame: 1 year
1 year
Evaluate 89Zr-AMG211 as a complementary tool for improved patient selection for targeted therapy with AMG 211.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

May 3, 2017

Study Completion (Actual)

May 3, 2017

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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