Cancer, Metastatic Castration-resistant Prostate Cancer, MCRPC
Conditions
Brief summary
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.
Interventions
DRUG30 mCi NYMO32
The initial dose is set at 30 mCi.
DRUG50 mCi NYMO32
The dose will be escalated to 50 mCi.
DRUG80 mCi NYMO32
The dose will be escalated to 80 mCi.
DRUG130 mCi NYMO32
The dose will be escalated to 130 mCi.
DRUG200 mCi NYMO32
The maximum dose is set at 200 mCi.
Sponsors
Zhengguo Chen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*\*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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA | 5-6 weeks after each administration. | 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. |
| 68Ga-NYM032 PET/CT | **5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.** | \*\*Reflect the PSMA expression level in the patient's lesions.\*\* |
Contacts
Primary ContactZhengGuo Chen ZGC ZhengGuo Chen
Outcome results
None listed