NCT05670106 - A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 16, 2023

Primary Completion Date

May 17, 2024

Study Completion Date

November 14, 2025

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

DRUG

[177Lu]Lu-PSMA-617

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

OTHER

Best supportive/best standard of care (BS/BSOC)

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

DRUG

68Ga-PSMA-11

Administered single intravenous dose of approximately 150 MBq. Administered dose could not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi).

Trial Locations (18)

100034

Novartis Investigative Site, Beijing

100036

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

200080

Novartis Investigative Site, Shanghai

210006

Novartis Investigative Site, Nanjing

210029

Novartis Investigative Site, Nanjing

300308

Novartis Investigative Site, Tianjin

430022

Novartis Investigative Site, Wuhan

450008

Novartis Investigative Site, Zhengzhou

450052

Novartis Investigative Site, Zhengzhou

510060

Novartis Investigative Site, Guangzhou

510120

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

710032

Novartis Investigative Site, Xian

710061

Novartis Investigative Site, Xian