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NOT YET RECRUITING
NCT06546527
EARLY_PHASE1

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

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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).

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-08-01

Completion Date

2026-12-01

Last Updated

2024-08-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

[177Lu]Lu-PSMA-137

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