NCT06546527

Study of [177Lu]Lu-PSMA-137 In Metastatic Castrate Resistant Prostate Cancer（mCRPC）

A Clinical Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Efficacy of [177Lu]Lu-PSMA-137 in Metastatic Castration Resistant Prostate Cancer（mCRPC）

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-center, single-arm clinical trial consisting of two parts. In Part A, 3 participants were enrolled to receive sequential administrations of low doses of \[177Lu\]Lu-PSMA-137 and \[177Lu\]Lu-PSMA-617. Pharmacokinetics（PK） sampling and single-photon emission computed tomography/computed tomography (SPECT/CT) scans were performed at scheduled time according to the protocol. Based on quantitative pharmacological results, the optimal dosing regimen for \[177Lu\]Lu-PSMA-137 was derived. In Part B, 3 participants were enrolled to receive treatments with 50% and 100% of the optimal dose of \[177Lu\]Lu-PSMA-137, to preliminarily evaluate the safety, tolerability, radiation dosimetry, and efficacy of \[177Lu\]Lu-PSMA-137 in participants with metastatic castration resistant prostate cancer (mCRPC).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	[177Lu]Lu-PSMA-137	\[177Lu\]Lu-PSMA-137 500 MBq;50% optimal dosing;100% optimal dosing

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-03-01
• Completion: 2026-12-01
• First posted: 2024-08-09
• Last updated: 2024-08-09