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

Sponsor
Norroy Bioscience Co., LTD
Study ID
NCT07795268
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177Lu-NYM032 injection — DRUG
    Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.
  • Best supportive/best standard of care — OTHER
    Best supportive/best standard of care as defined by the local investigator

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 177Lu-NYM032 plus BSC/BSoC
    Patients randomized to receive the investigational product will receive 7.4 GBq (+/- 10%) 177Lu-NYM032 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BSC/BSoC) may be used.
  • Other: BSC/BSoC alone
    Patients randomized to this arm will receive best supportive/best standard of care (BSC/BSoC) as determined by the investigator.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization until date of death from any cause, assessed up to 36months (estimated final OS analysis) ]

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