[Translation] A Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics/Radiation Dosimetry, and Efficacy of Radioactive 177Lu Injection in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer Patients
主要目的:
(1)评价177Lu-NYM032注射液在前列腺癌患者体内的安全性。
(2)确定177Lu-NYM032注射液的剂量限制性毒性(DLT),最大耐受剂量(MTD)和RP2D。
次要目的:
(1)评价177Lu-NYM032注射液在前列腺癌患者体内的药代动力学特征;
(2)评价177Lu-NYM032注射液在前列腺癌患者体内的全身和主要器官的放射性内照射吸收剂量和有效剂量。
(3)初步评价177Lu-NYM032注射液在前列腺癌患者药效学。
[Translation] Primary objectives:
(1) To evaluate the safety of 177Lu-NYM032 injection in patients with prostate cancer.
(2) To determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and RP2D of 177Lu-NYM032 injection.
Secondary objectives:
(1) To evaluate the pharmacokinetic characteristics of 177Lu-NYM032 injection in patients with prostate cancer;
(2) To evaluate the whole-body and major organ internal radiation absorbed dose and effective dose of 177Lu-NYM032 injection in patients with prostate cancer.
(3) To preliminarily evaluate the pharmacodynamics of 177Lu-NYM032 injection in patients with prostate cancer.