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

February 10, 2025 updated by: Zhengguo Chen
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ZhengGuo Chen ZGC ZhengGuo Chen
  • Phone Number: 0816-2226753
  • Email: 86753979@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

**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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 161Tb-NY032
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.**
**Reflect the PSMA expression level in the patient's lesions.**
**5-6 weeks after the second and fourth administrations in the same dose-escalation cohort.**

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhengguo Chen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 11, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MianyangNC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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