Clinical trial · Interventional
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM032 Injection Prepared by Kit for the Preparation of the 68Ga-NYM032 Injection in Patients With Prostate Cancer
NCT06389695CI-TRIAL-00090005completedPhase 1 / Phase 2ClinicalTrials.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)
68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted
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 |
|---|---|---|---|
| 68Ga-NYM032 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NYM032 injection
- interventionNames
- Drug: 68Ga-NYM032 injection
Primary outcomes (1)
- measure
- Incidence of Adverse Events
- timeFrame
- 5 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with pathologically confirmed prostate cancer; 2. Age range from 18 to 75 years old (including 18 and 75 years old); 3. ECOG score of 0 or 1; 4. Expected life ≥ 6 months; 5. The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration; 6. The subjects are able to maintain good communication with the researchers;understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations. Exclusion Criteria: 1. Known or suspected to be allergic to the investigational drug or any of its components; 2. Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer; 3. Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration; 4. Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study; 5. Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug; 6. Ongoing toxicity \>grade l from previous standard or investigational therapies; 7. Patients with active infections during screening; 8. Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination: 9. Other situations where the researchers believe that the subject is not suitable for inclusion in this study.
References
Publications (1)
- DERIVEDFu H, He H, Wang Y, Li W, Luo Y, Chen L, Mi Y, Sun C, Mao Y, Yu C. Preliminary evaluation of a novel PSMA-targeting radiopharmaceutical [68Ga]Ga/[177Lu]Lu-NYM032 for theranostic use in prostate cancer. Eur J Nucl Med Mol Imaging. 2025 Apr;52(5):1671-1684. doi: 10.1007/s00259-024-07046-5. Epub 2025 Jan 2. PMID 39745526