Clinical trial · Interventional
177Lu-labeled NY108 SPECT Imaging in Patients
NCT05815394CI-TRIAL-00065713unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-labeled NY108 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 177Lu-Anti-PSMA mAbs
- interventionNames
- Drug: 177Lu-labeled NY108
Primary outcomes (2)
- measure
- Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)
- timeFrame
- 1 year
- 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.
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- 1 year
- description
- Safety will be assessed by evaluation of incidence of adverse events.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.