Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer
1 other identifier
interventional
15
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2025
CompletedStudy Start
First participant enrolled
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 14, 2025
February 1, 2025
1.8 years
February 10, 2025
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
PSA
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
\*\*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.**
Study Arms (1)
161Tb-NY032
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhengguo Chenlead
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
February 10, 2025
First Posted
February 14, 2025
Study Start
February 11, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 14, 2025
Record last verified: 2025-02