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在晚期恶性肿瘤患者中评价注射用LS-HB光动力治疗的安全性、耐受性、药代动力学特征及初步有效性的I期临床研究。
[Translation] A phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LS-HB photodynamic therapy for injection in patients with advanced malignant tumors.
主要目的:评价注射用LS-HB在晚期恶性肿瘤受试者中的安全性及耐受性,并确定注射用LS-HB的II期推荐给药剂量(RP2D)和光动力治疗(PDT)参数。
次要目的:评价注射用LS-HB在晚期恶性肿瘤受试者中的药代动力学(PK)特征和初步有效性。
[Translation] Primary objective: To evaluate the safety and tolerability of LS-HB for injection in subjects with advanced malignant tumors, and to determine the Phase II recommended dose (RP2D) and photodynamic therapy (PDT) parameters of LS-HB for injection.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics and preliminary efficacy of LS-HB for injection in subjects with advanced malignant tumors.
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