177Lu-labeled NY108 SPECT Imaging in Patients

April 4, 2023 updated by: Chunjing Yu, Affiliated Hospital of Jiangnan University
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients voluntarily signed informed consent;
  2. Age 18-75, male;
  3. Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis;
  4. Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;
  5. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen;
  6. Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria;
  7. An ECOG score of 0-2

Exclusion Criteria:

  1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
  2. Patients with severe systemic or localized infections or other serious coexisting diseases;
  3. Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc;
  4. Patients with autoimmune diseases, including rheumatoid, etc;
  5. Inadequately controlled arrhythmias, including atrial fibrillation:
  6. Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);
  7. Uncontrolled hypertension;
  8. Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies;
  9. Subjects positive for syphilis, HBV, HCV, FIIV;
  10. Subjects of childbearing age who are unable to use effective contraceptive devices:
  11. Patients with a history of mental illness or related medical conditions;
  12. Patients who are unable or unavailable for SPECT/CT scanning;
  13. Other subjects who, in the opinion of the investigator, are not suitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 177Lu-Anti-PSMA mAbs
Drug: 177Lu-labeled NY108
Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 1 year
Safety will be assessed by evaluation of incidence of adverse events.
1 year
Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)
Time Frame: 1 year
Biodistribution of 177Lu-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Jiangnan University

Investigators

  • Principal Investigator: Chunjing Yu, Affiliated Hospital of Jiangnan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Anticipated)

March 3, 2024

Study Completion (Anticipated)

December 12, 2024

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS2023013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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