Metastatic Prostate CancerPhase 1/2IAB2MNCT01923727
Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer
A Phase 1/2 study testing [89Zr]Df-IAB2M in people with Metastatic Prostate Cancer, run by ImaginAb, Inc. at 1 site in United States.
Trial summary
This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of [89Zr]Df-IAB2M PET tracer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- [89Zr]Df-IAB2M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2016
- Phase
- Phase 1/2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male >/= 18 years of age
- Patients with histologically confirmed prostate cancer
- Progressive disease manifest (within 6 weeks of screening) by either
- imaging modalities (bone scan, MRI or CT) OR
- biochemical progression (PSA)
- Performance status of 60 or higher on Karnofsky scale
- Subject's schedule permits compliance with all study procedures
- Ability to understand and willingness to sign a written informed consent form
Who cannot join
- Previous anaphylactic reaction to huJ591 antibody or FDG imaging
- On any new anticancer therapy (GnRH analog allowed) while on the study
- Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
- Renal lab values: Creatinine > 1.5 ULN
- Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.
Read the detailed description
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- [89Zr]Df-IAB2M
- Keywords
- [89Zr]Df-IAB2M, Prostate, PET Scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[89Zr]Df-IAB2MBiological
A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.
| Study group | Role | What they receive |
|---|---|---|
| [89Zr]Df-IAB2M | Experimental | A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional). Receives: Biological: [89Zr]Df-IAB2M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
To assess the safety of a single dose of of [89Zr]Df-IAB2M
Measured: Day 1 (Infusion Day) through Day 7
Secondary outcomes (3)
[89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer
To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer
Measured: Day 1 (Infusion Day) to Day 3
Optimal parameters for imaging with [89Zr]Df-IAB2M
To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer
Measured: Day 1 (Infusion Day) to Day 3
Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer
To compare the results of the biopsy and FDG PET scan to the [89Zr]Df-IAB2M images
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImaginAb, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neeta Pandit-Taskar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923727
- Sponsor's protocol ID
- 002-2012
- Acronym
- IAB2M
- Status last verified
- Aug 2016
- First submitted
- 13 Aug 2013
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT01923727
- Acronym / sponsor ID
- IAB2M / 002-2012
- Conditions
- Metastatic Prostate Cancer
- Keywords
- [89Zr]Df-IAB2M, Prostate, PET Scan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- ImaginAb, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Aug 2013 (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.
This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.
Detailed description
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [89Zr]Df-IAB2M | Experimental | Biological: [89Zr]Df-IAB2MA single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult male >/= 18 years of age
- Patients with histologically confirmed prostate cancer
- Progressive disease manifest (within 6 weeks of screening) by either
- Performance status of 60 or higher on Karnofsky scale
- Subject's schedule permits compliance with all study procedures
Key exclusion criteria (5 listed)
- Previous anaphylactic reaction to huJ591 antibody or FDG imaging
- On any new anticancer therapy (GnRH analog allowed) while on the study
- Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
- Renal lab values: Creatinine > 1.5 ULN
- Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
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]Df-IAB2MA single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg. | Biological | [89Zr]Df-IAB2M |
Primary outcome
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
Time frame: Day 1 (Infusion Day) through Day 7
To assess the safety of a single dose of of [89Zr]Df-IAB2M
3 secondary outcomes
[89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer
Time frame: Day 1 (Infusion Day) to Day 3
Optimal parameters for imaging with [89Zr]Df-IAB2M
Time frame: Day 1 (Infusion Day) to Day 3
Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer
Time frame: Up to 4 weeks
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 13 Feb 2020.
- Individual participant dataSharing planned: Yes
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RecruitingPhase 2
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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.
Neeta Pandit-Taskar, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [89Zr]Df-IAB2M in people with Metastatic Prostate Cancer, run by ImaginAb, Inc. at 1 site in United States.
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 8 inclusion and 5 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer. (time frame: Day 1 (Infusion Day) through Day 7). 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 13 Feb 2020.