[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.

Start Date18 Oct 2024

Sponsor / Collaborator

Zhejiang Shimai Pharmaceutical Co., Ltd.

ChiCTR2400090635

/ Not yet recruitingPhase 1/2IIT

An Open-Label, Phase 1/2a, Single-Arm Study Assessing the Safety, Pharmacokinetics and Efficacy of CMDE005 in Patients with EGFR-Positive Advanced Solid Tumors

Start Date15 Oct 2024

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

100 Clinical Results associated with CMD-E005

100 Translational Medicine associated with CMD-E005

100 Patents (Medical) associated with CMD-E005

100 Deals associated with CMD-E005

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	Zhejiang Shimai Pharmaceutical Co., Ltd.	15 Oct 2024
EGFR mutation Solid Tumors	Phase 2	China	Zhejiang Shimai Pharmaceutical Co., Ltd.	15 Oct 2024
EGFR positive Neoplasms	IND Approval	United States	Zhejiang Shimai Pharmaceutical Co., Ltd.	25 Apr 2025

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