Clinical Trial · NCT03371420

PET Imaging of Subjects Using 124I-PU-AD

Overview

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.

Sponsor

QSAM Therapeutics, Inc.

Phase

Early Phase 1

Contacts

Robert Morgan, MS, JD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03371420

Eligibility

Inclusion

Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease: Cancer:
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.
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:
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.
Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist.
Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma.

Exclusion

Albumin \< 2 g/dl
AST/ALT \>2.5 x ULN
Bilirubin \> 1.5 x institutional upper limit of normal (ULN)
Subject has unacceptable pre-study organ function during screening defined as:
GGT \> 2.5 x ULN (IF Alkaline phosphatase \> 2.5 x ULN)
Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
Subject has history of acute major illness (i.e., unstable cardiovascular condition.)
Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min.