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Status unknownNCT05815394Updated Apr 18, 2023

177Lu-labeled NY108 SPECT Imaging in Patients

An Early Phase 1 interventional study of 177Lu-labeled NY108 in Prostate Cancer, sponsored by Affiliated Hospital of Jiangnan University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Affiliated Hospital of Jiangnan University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Male
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Study summary

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

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 10 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Affiliated Hospital of Jiangnan University is the lead sponsor of 28 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    177Lu-Anti-PSMA mAbs

    Drug: 177Lu-labeled NY108

Interventions

  • Drug177Lu-labeled NY108

    Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. Incidence of Treatment-Emergent Adverse Events

    Safety will be assessed by evaluation of incidence of adverse events.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Affiliated Hospital of Jiangnan University
    Wuxi, Jiangsu 214000, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05815394
Lead sponsor
Affiliated Hospital of Jiangnan University
Responsible party
Chunjing Yu (Director, Affiliated Hospital of Jiangnan University) — Principal investigator
First posted
Apr 18, 2023
Start date
Mar 3, 2023
Primary completion
Mar 3, 2024 (estimated)
Completion
Dec 12, 2024 (estimated)
Last update
Apr 18, 2023

Study contacts

Chunjing Yu
Contact
ycj_wxd1978@163.com
15312238622
Chunjing Yu
principal investigator · Affiliated Hospital of Jiangnan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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