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Active Not RecruitingNCT06383052

A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC

A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Radiation Dosimetry and Efficacy of 177Lu-NYM032 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Status
Active Not Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Norroy Bioscience Co., LTD · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA.

Conditions

Interventions

TypeNameDescription
DRUG177Lu-NYM032 injectionRadionuclide 177Lu will be used as a therapeutic nuclide for this study. The precursor of NYM032 will be labeled with 177Lu to form the chelation product, 177Lu-NYM032 injection which will be used in this study as a intravenous injection dose of 177Lu-NYM032. The radiation dose is chosen within the range of 50-200 mCi for an individual patient at every dose.

Timeline

Start date
2024-04-26
Primary completion
2025-06-30
Completion
2026-06-30
First posted
2024-04-25
Last updated
2025-05-21

Locations

1 site across 1 country: China

Regulatory

Source: ClinicalTrials.gov record NCT06383052. Inclusion in this directory is not an endorsement.

A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC (NCT06383052) · Clinical Trials Directory