[Translation] A Phase I, first-in-human, open-label, dose-escalation and dose-expansion clinical study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of TJ101 for injection in subjects with advanced solid tumors
剂量递增研究(Ia)
主要研究目的:
1.评估注射用TJ101在晚期实体瘤受试者中的安全性和耐受性。
剂量扩展研究(Ib)
主要研究目的:
1.评估注射用TJ101在RDEs剂量下在晚期实体瘤受试者中的安全性、耐受性和初步抗肿瘤活性。
2.确定注射用TJ101在晚期实体瘤受试者中的II期临床研究推荐剂量(RP2D)。
[Translation] Dose-Escalation Study (Ia)
Primary Study Objectives:
1. Evaluate the safety and tolerability of TJ101 for injection in subjects with advanced solid tumors.
Dose-Expansion Study (Ib)
Primary Study Objectives:
1. Evaluate the safety, tolerability, and preliminary anti-tumor activity of TJ101 for injection at the recommended dose (RDE) in subjects with advanced solid tumors.
2. Determine the recommended dose (RP2D) for the Phase II clinical study of TJ101 for injection in subjects with advanced solid tumors.