Back to resultsPET Imaging of Subjects Using 124I-PU-AD
Primary Purpose
Lymphoma, Solid Malignancy, Alzheimer Disease
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
PU-AD
PET Scan
Blood Draws
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
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:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Memorial Sloan Kettering
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
124I-PU-AD
Arm Description
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
Outcomes
Primary Outcome Measures
Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)
Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)
Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)
Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)
Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03371420
First Posted
November 29, 2017
Last Updated
April 13, 2023
Sponsor
Samus Therapeutics, Inc.
Collaborators
Memorial Sloan Kettering Cancer Center, Weill Medical College of Cornell University, Rockefeller University
1. Study Identification
Unique Protocol Identification Number
NCT03371420
Brief Title
PET Imaging of Subjects Using 124I-PU-AD
Official Title
PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Company has ceased operations
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samus Therapeutics, Inc.
Collaborators
Memorial Sloan Kettering Cancer Center, Weill Medical College of Cornell University, Rockefeller University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Solid Malignancy, Alzheimer Disease, Myeloma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
124I-PU-AD
Arm Type
Experimental
Arm Description
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
Intervention Type
Drug
Intervention Name(s)
PU-AD
Intervention Type
Device
Intervention Name(s)
PET Scan
Intervention Type
Other
Intervention Name(s)
Blood Draws
Primary Outcome Measure Information:
Title
Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)
Time Frame
1 week
Title
Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)
Time Frame
1 week
Title
Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)
Time Frame
1 week
Title
Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)
Time Frame
1 week
Title
Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Morgan, MS, JD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34344873
Citation
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.
Results Reference
derived
Learn more about this trial
PET Imaging of Subjects Using 124I-PU-AD
We'll reach out to this number within 24 hrs