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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 161Tb-NY032 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 mCi NYMO32 | Drug | The initial dose is set at 30 mCi. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PSA | 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. | 5-6 weeks after each administration. |
| 68Ga-NYM032 PET/CT | **Reflect the PSMA expression level in the patient's lesions.** | **5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.** |
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**1. Inclusion Criteria**
The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements.
Male, aged 18 years or older.
Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria.
Positive results on 68Ga-NYM032 positron emission tomography (PET)/computed tomography (CT) scan.
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.
ECOG performance status of 0-2.
Expected survival of ≥6 months.
Laboratory parameters must meet the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZhengGuo Chen ZGC ZhengGuo Chen | Contact | 0816-2226753 | 86753979@qq.com |
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| 50 mCi NYMO32 |
| Drug |
The dose will be escalated to 50 mCi. |
|
| 80 mCi NYMO32 | Drug | The dose will be escalated to 80 mCi. |
|
| 130 mCi NYMO32 | Drug | The dose will be escalated to 130 mCi. |
|
| 200 mCi NYMO32 | Drug | The maximum dose is set at 200 mCi. |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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