OncRef

Clinical Trial: 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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2026-09-15

Study Overview

Brief Summary

The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of [177Lu]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese participants with progressive PSMA-positive mCRPC who received at least 1 novel androgen receptor pathway inhibitor (ARPI) and were previously treated with 1 to 2 taxane regimens. Furthermore, the safety, PK, and dosimetry of [68Ga]Ga-PSMA-11 were assessed.

Data from this study will be used to bridge global pivotal phase III study (VISION, AAA617A12301) and to support China registration of [177Lu]Lu-PSMA-617 as a novel anticancer modality, namely radioligand therapy, in mCRPC.

Official Title

A Prospective, Open-label, Multi-center, Single-arm, Phase II Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Intervention / Treatment

  • Drug: [177Lu]Lu-PSMA-617
  • Other: Best supportive/best standard of care (BS/BSOC)
  • Drug: 68Ga-PSMA-11

Other Study ID Numbers

  • CAAA617A12201

Start Date (Actual)

2023-05-16

Primary Completion Date (Actual)

2024-05-17

Study Completion Date (Actual)

2026-04-22

Enrollment (Actual)

62

Study Type

Interventional

Phase

Phase 2