[Translation] Phase I/II clinical study to evaluate the safety and tolerability, radiation dosimetry and pharmacokinetic characteristics, and efficacy of [177Lu]Lu-XT033 injection in patients with metastatic prostate cancer
I期剂量验证研究
主要目的:评估[177Lu]Lu-XT033 注射液1.11Gbq 及 1.85Gbq 剂量组治疗mCRPC 患者的安全性和耐受性;评估单次给药的辐射剂量学和药代动力学特征。次要目的:评估两剂量组的疗效终点指标。
II期扩展研究
主要目的:评估基于 I 期剂量验证研究得到的 II 期推荐剂量(RP2D)联合标准治疗在不同转移性前列腺癌队列中的有效性。次要目的:评估其他疗效终点指标;评估安全性和耐受性。
[Translation] Phase I dose verification study
Primary objective: To evaluate the safety and tolerability of [177Lu]Lu-XT033 injection 1.11Gbq and 1.85Gbq dose groups in the treatment of mCRPC patients; to evaluate the radiation dosimetry and pharmacokinetic characteristics of a single dose. Secondary objective: To evaluate the efficacy endpoints of the two dose groups.
Phase II extension study
Primary objective: To evaluate the effectiveness of the Phase II recommended dose (RP2D) obtained based on the Phase I dose verification study combined with standard treatment in different metastatic prostate cancer cohorts. Secondary objective: To evaluate other efficacy endpoints; to evaluate safety and tolerability.