[Translation] A single-arm, open-label, multicenter Phase I/IIa clinical study to evaluate the safety, pharmacokinetic characteristics and efficacy of CMDE005 in patients with EGFR-positive advanced solid tumors
剂量递增Part A
主要目的:
评价CMDE005在EGFR阳性晚期实体瘤患者中的安全性。
次要目的:
评估CMDE005在EGFR阳性晚期实体瘤患者中的药代动力学(PK)特征;
评估CMDE005在EGFR阳性晚期实体瘤患者中的药效动力学(PD)特征;
评估CMDE005在EGFR阳性晚期实体瘤患者中的免疫原性;
评估CMDE005在EGFR阳性晚期实体瘤患者中的有效性,为后续临床试验提供剂量依据。
剂量扩展Part B
主要目的:
评价CMDE005在EGFR阳性晚期实体瘤患者中的有效性。
次要目的:
评价CMDE005在EGFR阳性晚期实体瘤患者中的安全性;
评价CMDE005在EGFR阳性晚期实体瘤患者中的PK特征;
评价CMDE005在EGFR阳性晚期实体瘤患者中的PD特征;
评价CMDE005在EGFR阳性晚期实体瘤患者中的免疫原性。
[Translation] Dose escalation Part A
Primary purpose:
To evaluate the safety of CMDE005 in patients with EGFR-positive advanced solid tumors.
Secondary purpose:
To evaluate the pharmacokinetic (PK) characteristics of CMDE005 in patients with EGFR-positive advanced solid tumors;
To evaluate the pharmacodynamic (PD) characteristics of CMDE005 in patients with EGFR-positive advanced solid tumors;
To evaluate the immunogenicity of CMDE005 in patients with EGFR-positive advanced solid tumors;
To evaluate the effectiveness of CMDE005 in patients with EGFR-positive advanced solid tumors and provide dosage basis for subsequent clinical trials.
Dose expansion Part B
Primary purpose:
To evaluate the effectiveness of CMDE005 in patients with EGFR-positive advanced solid tumors.
Secondary purpose:
To evaluate the safety of CMDE005 in patients with EGFR-positive advanced solid tumors;
To evaluate the PK characteristics of CMDE005 in patients with EGFR-positive advanced solid tumors;
To evaluate the PD characteristics of CMDE005 in patients with EGFR-positive advanced solid tumors;
To evaluate the immunogenicity of CMDE005 in patients with EGFR-positive advanced solid tumors.