Back to results89Zr-AMG211 PET Imaging Study
Primary Purpose
Advanced Gastrointestinal Cancer
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
89Zr-AMG211
89-ZrAMG211 PET
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastrointestinal Cancer
Eligibility Criteria
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
Sites / Locations
- VUmc
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
89Zr-AMG211 and 89Zr-AMG211 PET
Arm Description
Outcomes
Primary Outcome Measures
The quantitative uptake op 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value)
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT02760199
First Posted
March 15, 2016
Last Updated
June 1, 2017
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT02760199
Brief Title
89Zr-AMG211 PET Imaging Study
Official Title
89Zr-AMG211 PET Imaging in Patients With Relapsed/Refractory Gastrointestinal Adenocarcinoma Before and During Treatment With AMG 211
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 3, 2017 (Actual)
Study Completion Date
May 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastrointestinal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
89Zr-AMG211 and 89Zr-AMG211 PET
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
89Zr-AMG211
Intervention Description
Injection of 89Zr-AMG211 for imaging.
Intervention Type
Device
Intervention Name(s)
89-ZrAMG211 PET
Intervention Description
89Zr-AMG211 PET scan(s).
Primary Outcome Measure Information:
Title
The quantitative uptake op 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
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
Other Pre-specified Outcome Measures:
Title
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
Title
Evaluate 89Zr-AMG211 as a complementary tool for improved patient selection for targeted therapy with AMG 211.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. G.E. de Vries, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
VUmc
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
12. IPD Sharing Statement
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89Zr-AMG211 PET Imaging Study
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