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177Lu-labeled NY108 SPECT Imaging in Patients

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
177Lu-labeled NY108
Sponsored by
Affiliated Hospital of Jiangnan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male; Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis; Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive; Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen; Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria; An ECOG score of 0-2 Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with severe systemic or localized infections or other serious coexisting diseases; Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc; Patients with autoimmune diseases, including rheumatoid, etc; Inadequately controlled arrhythmias, including atrial fibrillation: Cardiac insufficiency (New York Heart Association (NYHA) work class criteria); Uncontrolled hypertension; Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies; Subjects positive for syphilis, HBV, HCV, FIIV; Subjects of childbearing age who are unable to use effective contraceptive devices: Patients with a history of mental illness or related medical conditions; Patients who are unable or unavailable for SPECT/CT scanning; Other subjects who, in the opinion of the investigator, are not suitable for enrollment.

Sites / Locations

  • Affiliated Hospital of Jiangnan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

177Lu-Anti-PSMA mAbs

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)
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.
Incidence of Treatment-Emergent Adverse Events
Safety will be assessed by evaluation of incidence of adverse events.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2023
Last Updated
April 4, 2023
Sponsor
Affiliated Hospital of Jiangnan University
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1. Study Identification

Unique Protocol Identification Number
NCT05815394
Brief Title
177Lu-labeled NY108 SPECT Imaging in Patients
Official Title
177Lu-labeled NY108 SPECT Imaging in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
March 3, 2024 (Anticipated)
Study Completion Date
December 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiangnan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
177Lu-Anti-PSMA mAbs
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
177Lu-labeled NY108
Intervention Description
Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.
Primary Outcome Measure Information:
Title
Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)
Description
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.
Time Frame
1 year
Title
Incidence of Treatment-Emergent Adverse Events
Description
Safety will be assessed by evaluation of incidence of adverse events.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male; Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis; Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive; Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen; Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria; An ECOG score of 0-2 Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with severe systemic or localized infections or other serious coexisting diseases; Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc; Patients with autoimmune diseases, including rheumatoid, etc; Inadequately controlled arrhythmias, including atrial fibrillation: Cardiac insufficiency (New York Heart Association (NYHA) work class criteria); Uncontrolled hypertension; Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies; Subjects positive for syphilis, HBV, HCV, FIIV; Subjects of childbearing age who are unable to use effective contraceptive devices: Patients with a history of mental illness or related medical conditions; Patients who are unable or unavailable for SPECT/CT scanning; Other subjects who, in the opinion of the investigator, are not suitable for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunjing Yu
Organizational Affiliation
Affiliated Hospital of Jiangnan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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177Lu-labeled NY108 SPECT Imaging in Patients

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