Advanced Accelerator Applications (Italy) SRL

To evaluate the efficacy and safety of AAA617 alone and in combination with an androgen receptor pathway inhibitor (ARPI) in subjects with PSMA-positive castration-resistant prostate cancer who have no evidence of metastasis on conventional imaging (CI; i.e., CT/MRI and bone scan).

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and radiation dosimetry of [177Lu]Lu-PSMA-617 added to best supportive/best standard of care (BSC/BSoC) in Chinese subjects with progressive PSMA-positive mCRPC who have received 1-2 prior taxane regimens and at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy. In addition, the safety, PK, and radiation dosimetry of [68Ga]Ga-PSMA-11 were also evaluated. The data from this study will be used to bridge the global pivotal Phase III study (VISION, AAA617A12301) and support the registration of [177Lu]Lu-PSMA-617 as a novel anticancer therapy (i.e., radioligand therapy) for mCRPC in China.

This study aims to evaluate the effectiveness of [177Lu]Lu-PSMA-617 in prolonging rPFS compared with switching to another androgen receptor-directed therapy. The primary endpoint, rPFS, will be assessed by blinded independent central review.