[Translation] A dose-escalation, phase I clinical study evaluating the safety, tolerability, tissue distribution, pharmacokinetics, radiation dosimetry, and initial efficacy of 177Lu-PSMA-VG01 injection in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
主要目的:评价177Lu-PSMA-VG01注射液用于治疗PSMA阳性的转移性去势抵抗性前列腺癌(mCRPC)患者的安全性和耐受性。评价177Lu-PSMA-VG01注射液的药代动力学(PK)、生物分布和辐射剂量学特征。确定RP2D。
次要目的:探索177Lu-PSMA-VG01注射液在PSMA阳性的转移性去势抵抗性前列腺癌(mCRPC)患者中的初步抗肿瘤活性。考察研究药物在人体内的稳定性。
[Translation] Primary Objective: To evaluate the safety and tolerability of 177Lu-PSMA-VG01 injection in the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). To evaluate the pharmacokinetic (PK), biodistribution, and radiation dosimetry characteristics of 177Lu-PSMA-VG01 injection. To determine the RP2D.
Secondary Objective: To explore the preliminary antitumor activity of 177Lu-PSMA-VG01 injection in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). To investigate the stability of the drug in humans.