Advanced Gastrointestinal CancerPhase 1NCT02760199
89Zr-AMG211 PET Imaging Study
A Phase 1 study testing 89Zr-AMG211 and 89-ZrAMG211 PET in people with Advanced Gastrointestinal Cancer, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastrointestinal Cancer
- What is being tested?
- 89Zr-AMG211 and 89-ZrAMG211 PET
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesNetherlands
- Study dates
- Aug 2016to 3 May 2017
- 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 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VUmc
Amsterdam, 1081 HV
University Medical Center Groningen
Groningen, 9713 GZ
About this study
Official title: 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.
- Conditions
- Advanced Gastrointestinal Cancer
- Being tested
- 89Zr-AMG211, 89-ZrAMG211 PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-AMG211Drug
Injection of 89Zr-AMG211 for imaging.
89-ZrAMG211 PETDevice
89Zr-AMG211 PET scan(s).
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-AMG211 and 89Zr-AMG211 PET | Experimental | Not described Receives: Drug: 89Zr-AMG211; Device: 89-ZrAMG211 PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantitative uptake op 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value)
Measured: 1 year
Secondary outcomes (2)
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).
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startAug 2016
- Primary completion3 May 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E. G.E. de Vries, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760199
- Sponsor's protocol ID
- 20150930
- Status last verified
- May 2024
- First submitted
- 15 Mar 2016
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 89Zr-AMG211 PET Imaging in Patients With Relapsed/Refractory Gastrointestinal Adenocarcinoma Before and During Treatment With AMG 211
- ClinicalTrials.gov ID
- NCT02760199
- Acronym / sponsor ID
- 20150930
- Conditions
- Advanced Gastrointestinal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-AMG211 and 89Zr-AMG211 PET | Experimental | Drug: 89Zr-AMG211, Device: 89-ZrAMG211 PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-AMG211Injection of 89Zr-AMG211 for imaging. | Drug | 89Zr-AMG211 and 89Zr-AMG211 PET |
| 89-ZrAMG211 PET89Zr-AMG211 PET scan(s). | Device | 89Zr-AMG211 and 89Zr-AMG211 PET |
Primary outcome
The quantitative uptake op 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value)
Time frame: 1 year
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. G.E. de Vries, MD, PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-AMG211 and 89-ZrAMG211 PET in people with Advanced Gastrointestinal Cancer, run by University Medical Center Groningen at 2 sites in Netherlands.
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 10 inclusion and 10 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 3 May 2024. 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 Netherlands. 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?
The quantitative uptake op 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2024.