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PET Imaging of Subjects Using 124I-PU-AD

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ClinicalTrials.gov Identifier: NCT03371420
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Rockefeller University
Information provided by (Responsible Party):
Samus Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma Solid Malignancy Alzheimer Disease Myeloma Drug: PU-AD Device: PET Scan Other: Blood Draws Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : June 10, 2019


Arm Intervention/treatment
Experimental: 124I-PU-AD
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
Drug: PU-AD
Device: PET Scan
Other: Blood Draws



Primary Outcome Measures :
  1. Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC) [ Time Frame: 1 week ]
  2. Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax) [ Time Frame: 1 week ]
  3. Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin) [ Time Frame: 1 week ]
  4. Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2) [ Time Frame: 1 week ]
  5. Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax) [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 30 days ]
    Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease:

    Cancer:

    1. Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma.
    2. Cancer histology confirmed by pathology.
    3. Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1).

    Alzheimer's:

    1. 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.
    2. Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist.
  2. 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.

Exclusion Criteria:

  1. Subject has unacceptable pre-study organ function during screening defined as:

    1. Bilirubin > 1.5 x institutional upper limit of normal (ULN)
    2. AST/ALT >2.5 x ULN
    3. Albumin < 2 g/dl
    4. GGT > 2.5 x ULN (IF Alkaline phosphatase > 2.5 x ULN)
    5. Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.
  2. Subject has history of acute major illness (i.e., unstable cardiovascular condition.)
  3. Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371420


Locations
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United States, New York
Memorial Sloan Kettering
New York, New York, United States, 10065
Sponsors and Collaborators
Samus Therapeutics, Inc.
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Rockefeller University
Investigators
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Study Director: Robert Morgan, MS, JD Sponsor GmbH
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Responsible Party: Samus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03371420    
Obsolete Identifiers: NCT02751554
Other Study ID Numbers: PU-AD-00-001
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders