LymphomaEarly Phase 1NCT03371420
PET Imaging of Subjects Using 124I-PU-AD
A Early Phase 1 study testing PU-AD, PET Scan and Blood Draws in people with Lymphoma and Solid Malignancy, run by Samus Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Lymphoma, Solid Malignancy, Alzheimer Disease
- What is being tested?
- PU-AD, PET Scan and Blood Draws
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 10 Jun 2019
- Phase
- Early 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease:
- Cancer:
- Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma.
- Cancer histology confirmed by pathology.
- Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1).
- Alzheimer's:
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- Established diagnosis of mild-moderate Alzheimer's disease based upon neurological and neuropsychological evaluation following the National Institute on Aging - Alzheimer's disease Association criteria that recently revisited the NINCDS-ADRDA criteria.
- Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist.
- Subjects who have both cancer and Alzheimer's Disease, subjects are considered eligible if they meet all eligibility requirements for either Alzheimer's Disease or cancer patients, as specified above.
Who cannot join
- Subject has unacceptable pre-study organ function during screening defined as:
- Bilirubin > 1.5 x institutional upper limit of normal (ULN)
- AST/ALT >2.5 x ULN
- Albumin < 2 g/dl
- GGT > 2.5 x ULN (IF Alkaline phosphatase > 2.5 x ULN)
- Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.
- Subject has history of acute major illness (i.e., unstable cardiovascular condition.)
- Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study
This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.
Read the detailed description
This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot (microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD.
Following a 28-day screening period, eligible subjects will return to the clinic on Day 1. A single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects.
After 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood samples will also be obtained at multiple time points.
Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.
- Conditions
- Lymphoma, Solid Malignancy, Alzheimer Disease, Myeloma
- Being tested
- PU-AD, PET Scan, Blood Draws
- Medical subject headings
- Lymphoma, Alzheimer Disease, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PU-ADDrug
PET ScanDevice
Blood DrawsOther
| Study group | Role | What they receive |
|---|---|---|
| 124I-PU-AD | Experimental | A single dose of 124I-PU-AD will be administered by intravenous (IV) injection Receives: Drug: PU-AD; Device: PET Scan; Other: Blood Draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)
Measured: 1 week
Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)
Measured: 1 week
Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)
Measured: 1 week
Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)
Measured: 1 week
Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)
Measured: 1 week
Secondary outcomes (1)
Incidence of adverse events
Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startApr 2016
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Why it stopped: Company has ceased operations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center, Weill Medical College of Cornell University, Rockefeller University
- Responsible party
- Sponsor
- Investigators
- Robert Morgan, MS, JD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371420
- Sponsor's protocol ID
- PU-AD-00-001
- Status last verified
- Jun 2019
- First submitted
- 29 Nov 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bolaender A, Zatorska D, He H, Joshi S, Sharma S, Digwal CS, Patel HJ, Sun W, Imber BS, Ochiana SO, Patel MR, Shrestha L, Shah SK, Wang S, Karimov R, Tao H, Patel PD, Martin AR, Yan P, Panchal P, Almodovar J, Corben A, Rimner A, Ginsberg SD, Lyashchenko S, Burnazi E, Ku A, Kalidindi T, Lee SG, Grkovski M, Beattie BJ, Zanzonico P, Lewis JS, Larson S, Rodina A, Pillarsetty N, Tabar V, Dunphy MP, Taldone T, Shimizu F, Chiosis G. Chemical tools for epichaperome-mediated interactome dysfunctions of the central nervous system. Nat Commun. 2021 Aug 3;12(1):4669. doi: 10.1038/s41467-021-24821-2.
PubMed 34344873
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study
- ClinicalTrials.gov ID
- NCT03371420
- Acronym / sponsor ID
- PU-AD-00-001
- Conditions
- Lymphoma, Solid Malignancy, Alzheimer Disease, Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company has ceased operations
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Samus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center, Weill Medical College of Cornell University, Rockefeller University
- Study start
- Apr 2016 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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 first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.
Detailed description
This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot (microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD.
Following a 28-day screening period, eligible subjects will return to the clinic on Day 1. A single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects.
After 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood samples will also be obtained at multiple time points.
Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 124I-PU-AD | Experimental | Drug: PU-AD, Device: PET Scan, Other: Blood DrawsA single dose of 124I-PU-AD will be administered by intravenous (IV) injection |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease:
- Subjects who have both cancer and Alzheimer's Disease, subjects are considered eligible if they meet all eligibility requirements for either Alzheimer's Disease or cancer patients, as specified above.
Key exclusion criteria (8 listed)
- Subject has unacceptable pre-study organ function during screening defined as:
- Subject has history of acute major illness (i.e., unstable cardiovascular condition.)
- Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
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 |
|---|---|---|
| PU-AD | Drug | 124I-PU-AD |
| PET Scan | Device | 124I-PU-AD |
| Blood Draws | Other | 124I-PU-AD |
Primary outcome
Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)
Time frame: 1 week
Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)
Time frame: 1 week
Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)
Time frame: 1 week
Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)
Time frame: 1 week
Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)
Time frame: 1 week
1 secondary outcome
Incidence of adverse events
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Company has ceased operations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 34344873Bolaender A, Zatorska D, He H, Joshi S, Sharma S, Digwal CS, Patel HJ, Sun W, Imber BS, Ochiana SO, Patel MR, Shrestha L, Shah SK, Wang S, Karimov R, Tao H, Patel PD, Martin AR, Yan P, Panchal P, Almodovar J, Corben A, Rimner A, Ginsberg SD, Lyashchenko S, Burnazi E, Ku A, Kalidindi T, Lee SG, Grkovski M, Beattie BJ, Zanzonico P, Lewis JS, Larson S, Rodina A, Pillarsetty N, Tabar V, Dunphy MP, Taldone T, Shimizu F, Chiosis G. Chemical tools for epichaperome-mediated interactome dysfunctions of the central nervous system. Nat Commun. 2021 Aug 3;12(1):4669. doi: 10.1038/s41467-021-24821-2.
- Individual participant dataSharing planned: No
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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.
Robert Morgan, MS, JD study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PU-AD, PET Scan and Blood Draws in people with Lymphoma and Solid Malignancy, run by Samus Therapeutics, 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Company has ceased operations). Results are not available in the source record.
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?
Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC) (time frame: 1 week). The study lists 5 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 NCT03371420, 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 18 Apr 2023.