Sign in

NCT06827080Not yet recruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
15 (estimated)
First submitted
10 Feb 2025
Start date
11 Feb 2025
Primary completion date
1 Dec 2026
Lead sponsor
Zhengguo Chen
NCT number
NCT06827080

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 15
  • From 11 Feb 2025 to the primary completion date, 1 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • \*\*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:
    • 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.
    • Blood counts: WBC ≥3.5×10\^9/L, PLT ≥100×10\^9/L, Hb ≥90 g/L.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.