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Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT07795268 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-08-31

No results posted yet for this study

Summary

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-NYM032 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

Conditions

Interventions

DRUG

177Lu-NYM032 injection

Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.

OTHER

Best supportive/best standard of care

Best supportive/best standard of care as defined by the local investigator

Sponsors & Collaborators

  • Norroy Bioscience Co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-11-30
Completion
2029-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795268 on ClinicalTrials.gov