[Translation] A single-arm, open-label, dose-escalation, and expansion phase I/II clinical trial evaluating the safety, tolerability, clinicophagus pharmacology, and preliminary efficacy of gallium [68Ga]PSMA-0057 injection and lutetium [177Lu]PSMA-0057 injection in patients with PSMA-positive metastatic castration-resistant prostate cancer.
I期主要目的:在PSMA阳性的转移性去势抵抗性前列腺癌(mCRPC)患者中评价镓[68Ga]PSMA-0057注射液和镥[177Lu]PSMA-0057注射液作为诊疗一体化方案的安全性和耐受性,并确定177Lu-PSMA-0057最大耐受剂量(MTD)和/或II期临床试验推荐给药方案。
II期主要目的:在PSMA阳性的mCRPC患者中评价68Ga-PSMA-0057注射液和177Lu-PSMA-0057注射液作为诊疗一体化方案的初步有效性。
[Translation] Phase I Primary Objective: To evaluate the safety and tolerability of gallium [68Ga]PSMA-0057 injection and lutetium [177Lu]PSMA-0057 injection as a therapeutic regimen in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), and to determine the maximum tolerated dose (MTD) of 177Lu-PSMA-0057 and/or the recommended dosing regimen from the Phase II clinical trial.
Phase II Primary Objective: To evaluate the preliminary efficacy of 68Ga-PSMA-0057 injection and 177Lu-PSMA-0057 injection as a therapeutic regimen in patients with PSMA-positive mCRPC.