[Translation] A multicenter, open-label phase Ib/II clinical trial evaluating the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of [177Lu]Lu-XT381 injection in the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer.
主要目的
1)评价[177Lu]Lu-XT381注射液的安全性和耐受性;
2)初步评估[177Lu]Lu-XT381注射液单药治疗前列腺特异性膜抗原(PSMA)阳性的转移性去势抵抗性前列腺癌试验参与者的有效性(PSA50缓解率及ORR);
3)确定[177Lu]Lu-XT381注射液单药治疗前列腺特异性膜抗原(PSMA)阳性的转移性去势抵抗性前列腺癌试验参与者的II期临床研究推荐剂量(RP2D)。
次要目的
1)进一步评价[177Lu]Lu-XT381注射液的安全性和耐受性;
2)评估[177Lu]Lu-XT381注射液单药治疗前列腺特异性膜抗原(PSMA)阳性的转移性去势抵抗性前列腺癌试验参与者的疗效(疗效指标:PSA90、PSA最大缓解、至PSA进展时间、rPFS、DOR、DCR、OS、SSE);
3)评估[177Lu]Lu-XT381注射液的辐射剂量学特征;
4)评价[177Lu]Lu-XT381注射液的PK特征。
[Translation] Primary Objectives:
1) To evaluate the safety and tolerability of [177Lu]Lu-XT381 injection;
2) To preliminarily assess the efficacy (PSA50 response rate and ORR) of [177Lu]Lu-XT381 injection monotherapy in participants of a trial of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer;
3) To determine the recommended dose (RP2D) for a phase II clinical trial of [177Lu]Lu-XT381 injection monotherapy in participants of a trial of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. Secondary objectives:
1) To further evaluate the safety and tolerability of [177Lu]Lu-XT381 injection;
2) To assess the efficacy of [177Lu]Lu-XT381 injection monotherapy in participants of a trial of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (efficacy endpoints: PSA90, maximum PSA response, time to PSA progression, rPFS, DOR, DCR, OS, SSE);
3) To evaluate the radiation dosimetry characteristics of [177Lu]Lu-XT381 injection;
4) To evaluate the pharmacokinetic characteristics of [177Lu]Lu-XT381 injection.