PET Imaging of Subjects Using 124I-PU-AD

NCT03371420 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: PU-AD-00-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Solid Malignancy; Alzheimer Disease; Myeloma

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)

  1 week

• Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)

  1 week

• Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)

  1 week

• Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)

  1 week

• Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)

  1 week

Secondary Outcomes (1)

• Incidence of adverse events

  30 days

Study Arms (1)

124I-PU-AD

EXPERIMENTAL

A single dose of 124I-PU-AD will be administered by intravenous (IV) injection

Drug: PU-AD; Device: PET Scan; Other: Blood Draws

Interventions

PU-AD DRUG

124I-PU-AD

PET Scan DEVICE

124I-PU-AD

Blood Draws OTHER

124I-PU-AD

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samus Therapeutics, Inc.: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Weill Medical College of Cornell University: collaborator
• Rockefeller University: collaborator

Study Sites (1)

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 34344873 DERIVED

MeSH Terms

Conditions

Lymphoma; Alzheimer Disease; Neoplasms, Plasma Cell

Interventions

Positron-Emission Tomography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Robert Morgan, MS, JD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 13, 2017
• Study Start: April 1, 2016
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: April 18, 2023

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)