PET Imaging of Subjects Using 124I-PU-AD

• Status: Completed
• Trial end date: 2019-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center; Samus Therapeutics, Inc.
• Collaborators: Memorial Sloan Kettering Cancer Center; Rockefeller University; Weill Medical College of Cornell University

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.