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NCT Number: NCT06827080

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

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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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer, MCRPC Cancer Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

**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.

Treatment and study plan

30 mCi NYMO32

Drug

The initial dose is set at 30 mCi.

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.

Primary outcomes

  1. PSA

    Time frame: 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.

  2. 68Ga-NYM032 PET/CT

    Time frame: **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.**

Study contacts

Contact information is provided by the study sponsor or research team.

ZhengGuo Chen ZGC ZhengGuo Chen

CONTACT

[email protected]

0816-2226753

Sponsors and collaborators

Lead sponsor

Zhengguo Chen

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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