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Not yet recruiting NCT06827080

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

Phase I / Phase II Interventional Metastatic Castration-resistant Prostate Cancer, MCRPC Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 30 mCi NYMO32, 50 mCi NYMO32, 80 mCi NYMO32, 130 mCi NYMO32.
Who it may be relevant to
Registry conditions: Metastatic Castration-resistant Prostate Cancer, MCRPC, Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug 30 mCi NYMO32
    The initial dose is set at 30 mCi.
  • Drug 50 mCi NYMO32
    The dose will be escalated to 50 mCi.
  • Drug 80 mCi NYMO32
    The dose will be escalated to 80 mCi.
  • Drug 130 mCi NYMO32
    The dose will be escalated to 130 mCi.
  • Drug 200 mCi NYMO32
    The maximum dose is set at 200 mCi.

Primary outcome measures

  • PSA [Time frame: 5-6 weeks after each administration.]
  • 68Ga-NYM032 PET/CT [Time frame: **5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.**]

Eligibility criteria

\*\*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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06827080 · MianyangNC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗