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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
注射用PTX-912在局部晚期或转移性实体瘤患者的多中心、开放标签Ia/Ib期临床研究。
[Translation] A multicenter, open-label, Phase Ia/Ib clinical study of PTX-912 for injection in patients with locally advanced or metastatic solid tumors.
主要目的:
1.评估PTX-912在局部晚期或转移性实体瘤患者中的安全性和耐受性。
2.通过剂量限制性毒性(DLT)评估确定最大耐受剂量(MTD)、最佳生物学剂量(OBD)和/或II期临床试验推荐剂量(RP2D)。
次要目的:
1.评价PTX-912在局部晚期或转移性实体瘤患者中的药代动力学(Pharmacokinetics,PK)特征和免疫原性。
[Translation] Primary objectives:
1. To evaluate the safety and tolerability of PTX-912 in patients with locally advanced or metastatic solid tumors.
2. To determine the maximum tolerated dose (MTD), optimal biological dose (OBD) and/or recommended dose for Phase II clinical trials (RP2D) through dose-limiting toxicity (DLT) evaluation.
Secondary objectives:
1. To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of PTX-912 in patients with locally advanced or metastatic solid tumors.
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