Clinical trial · Interventional
Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer
NCT06827080CI-TRIAL-00086027not yet recruitingPhase 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)
161Tb-NYM032 is a radiopharmaceutical labeled with a PSMA ligand, used for the treatment of metastatic castration-resistant prostate cancer, which is needed for clinical trial to be conducted.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Castration-resistant Prostate Cancer, MCRPC | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 130 mCi NYMO32 | Drug | — | UNRESOLVED |
| 200 mCi NYMO32 | Drug | — | UNRESOLVED |
| 30 mCi NYMO32 | Drug | — | UNRESOLVED |
| 50 mCi NYMO32 | Drug | — | UNRESOLVED |
| 80 mCi NYMO32 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 161Tb-NY032
- interventionNames
- Drug: 30 mCi NYMO32
- Drug: 50 mCi NYMO32
- Drug: 80 mCi NYMO32
- Drug: 130 mCi NYMO32
- Drug: 200 mCi NYMO32
Primary outcomes (2)
- measure
- PSA
- timeFrame
- 5-6 weeks after each administration.
- description
- PSA levels can be used to monitor the treatment efficacy, disease progression, or recurrence of prostate cancer. A decrease in PSA levels after treatment usually indicates effective therapy, while an increase in PSA levels may suggest disease recurrence or progression.
- measure
- 68Ga-NYM032 PET/CT
- timeFrame
- **5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.**
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
\*\*1. Inclusion Criteria\*\* 1. The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements. 2. Male, aged 18 years or older. 3. Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria. 4. Positive results on 68Ga-NYM032 positron emission tomography (PET)/computed tomography (CT) scan. 5. Must have received at least one NAAD treatment (e.g., enzalutamide and/or abiraterone) or at least one taxane-based treatment regimen, or be intolerant to or refuse taxane therapy for metastatic castration-resistant prostate cancer. 6. ECOG performance status of 0-2. 7. Expected survival of ≥6 months. 8. Laboratory parameters must meet the following: 1. ALT and AST must not exceed 3 times the upper limit of normal (ULN); BUN and Cr must not exceed 1.5 times the ULN. 2. Blood counts: WBC ≥3.5×10\^9/L, PLT ≥100×10\^9/L, Hb ≥90 g/L.
References
Publications (0)
Data not yet available
No reference posted for this study.