[Translation] An open-label, multicenter, dose-escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of DNV3 combined with toripalimab in patients with advanced/metastatic solid tumors and lymphomas
剂量递增 Part A
主要目的:
评价 DNV3 联合特瑞普利单抗在晚期/转移性实体瘤和淋巴瘤患者中的安全性及耐受性,探索后续联合用药推荐剂量。
次要目的:
评价 DNV3 联合特瑞普利单抗在晚期/转移性实体瘤和淋巴瘤患者中的药代动力学(PK)特征、免疫原性,为后续临床试验提供剂量依据。
探索性目的:
探索 DNV3 联合特瑞普利单抗在晚期/转移性实体瘤和淋巴瘤患者中的药效学(PD)特征;探索在晚期/转移性期实体瘤和淋巴瘤患者的组织样本中肿瘤浸润淋巴细胞(TIL)、PD-L1 和淋巴细胞激活基因 3(LAG-3)的表达与临床疗效的关系。
剂量扩展 Part B
主要目的:
评价 DNV3 联合特瑞普利单抗在扩展阶段特定瘤种患者中的抗肿瘤活性;
次要目的:
评价 DNV3 联合特瑞普利单抗在扩展阶段特定瘤种患者中的安全性、药代动力学(PK)特征和免疫原性。
探索性目的: 探索在晚期/转移性期实体瘤和淋巴瘤患者的组织样本中肿瘤浸润淋巴细胞(TIL)、PD-L1 和淋巴细胞激活基因 3(LAG-3)的表达与临床疗效的关系。
[Translation] Dose escalation Part A
Main purpose:
To evaluate the safety and tolerability of DNV3 combined with Teplizumab in patients with advanced/metastatic solid tumors and lymphomas, and to explore the recommended dose for subsequent combined medication.
Secondary purpose:
To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of DNV3 combined with Teplizumab in patients with advanced/metastatic solid tumors and lymphomas, and to provide a dose basis for subsequent clinical trials.
Exploratory purpose:
To explore the pharmacodynamic (PD) characteristics of DNV3 combined with Teplizumab in patients with advanced/metastatic solid tumors and lymphomas; to explore the relationship between the expression of tumor infiltrating lymphocytes (TIL), PD-L1 and lymphocyte activation gene 3 (LAG-3) in tissue samples of patients with advanced/metastatic solid tumors and lymphomas and clinical efficacy.
Dose expansion Part B
Primary purpose:
To evaluate the anti-tumor activity of DNV3 combined with Teplizumab in patients with specific tumor types in the expansion phase;
Secondary purpose:
To evaluate the safety, pharmacokinetic (PK) characteristics and immunogenicity of DNV3 combined with Teplizumab in patients with specific tumor types in the expansion phase.
Exploratory purpose: To explore the relationship between the expression of tumor infiltrating lymphocytes (TIL), PD-L1 and lymphocyte activation gene 3 (LAG-3) and clinical efficacy in tissue samples of patients with advanced/metastatic solid tumors and lymphomas.