Status:
TERMINATED
PET Imaging of Subjects Using 124I-PU-AD
Lead Sponsor:
Samus Therapeutics, Inc.
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Conditions:
Lymphoma
Solid Malignancy
Eligibility:
All Genders
21-90 years
Phase:
EARLY_PHASE1
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 Alzhei...
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, m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03371420
Start Date
April 1 2016
End Date
June 10 2019
Last Update
April 18 2023
Active Locations (1)
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1
Memorial Sloan Kettering
New York, New York, United States, 10065