Clinical trial · Interventional
Phase 0/1 Study of 212Pb-NG001 in mCRPC
Phase 0/1 Theragnostic Study in Patients With Metastatic Castration Resistant Prostate Cancer in Need of Salvage Therapy, Selected by 18F-PSMA-PET Imaging and Treated by Alpha-therapeutic Radioligand 212Pb-NG001
NCT05725070CI-TRIAL-00070247completedEarly 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)
The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.
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 |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 212Pb-NG001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drug
- description
- 212Pb-NG001
- interventionNames
- Drug: 212Pb-NG001
Primary outcomes (1)
- measure
- Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
- timeFrame
- Up to 28 days
- description
- To qualitatively determine whether 212Pb-NG001 can be used to produce images of sufficient clarity and sensitivity by SPECT/CT to confirm 212Pb-NG001 uptake and biodistribution.
Secondary outcomes (3)
- measure
- Safety and tolerability
- timeFrame
- Up to 28 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * ECOG performance status of 0 to 2 * Life expectancy \>6 months * Histological, pathological, and/or cytological confirmation of prostate cancer * Metastatic castration resistant prostate cancer * Failure of conventional treatment or such treatment not available/accepted by patient * PSMA avid mCRPC lesions confirmed by PSMA PET/CT * Adequate hematopoietic, kidney and liver function Key Exclusion Criteria: * Concurrent or other cancer diagnosis last two years, except for carcinoma in situ * Concomitant diseases not compatible for radioactive therapy * Previous PSMA-targeted radioligand therapy * Concurrent serious (as determined by the Principal Investigator) medical conditions Note: Other protocol defined Inclusion/Exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.