Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer

Launched by ZHENGGUO CHEN · Feb 10, 2025

Keywords

ClinConnect Summary

The clinical trial titled "Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer" is investigating a new treatment called 161Tb-NYM032 for men who have advanced prostate cancer that has not responded to hormone therapy. This treatment uses a special radioactive substance that targets cancer cells, and the study aims to learn about its safety, how well it is tolerated, and its initial effectiveness.

To participate in this trial, men must be at least 18 years old and have been diagnosed with metastatic castration-resistant prostate cancer, which means the cancer has spread and is no longer responding to hormone treatments. They should have also had prior treatments for their cancer. Participants will undergo tests to ensure they meet specific health criteria and will need to sign a consent form agreeing to take part in the study. Although the trial is not yet recruiting, it will provide an opportunity for eligible men to explore a potential new treatment option.

Gender

MALE

Eligibility 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.