[Translation] A multicenter, open-label, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor activity of SYS6041 in advanced solid tumors

剂量递增阶段主要目的：评估SYS6041治疗晚期实体瘤参与者的安全性和耐受性确定SYS6041的RP2D 次要目的：评估SYS6041的抗肿瘤活性评估SYS6041在晚期实体瘤参与者中的PK特征评估SYS6041在晚期实体瘤参与者中的免疫原性探索性目的：评估肿瘤组织中的FRα表达水平以及外周血中sFRα的表达水平与临床疗效/安全性的相关性队列扩展阶段主要目的：评估SYS6041在RP2D剂量下治疗晚期实体瘤的抗肿瘤活性次要目的：评估SYS6041在晚期实体瘤中的抗肿瘤活性评估SYS6041在晚期实体瘤中的安全性和耐受性评估SYS6041在晚期实体瘤参与者中的PK特征评估SYS6041在晚期实体瘤参与者中的免疫原性探索性目的：评估组织样本FRα表达水平以及外周血中sFRα的表达水平与临床疗效/安全性的相关性

[Translation]

Dose escalation phase Primary objectives: To evaluate the safety and tolerability of SYS6041 in participants with advanced solid tumors Determine the RP2D of SYS6041 Secondary objectives: To evaluate the anti-tumor activity of SYS6041 To evaluate the PK characteristics of SYS6041 in participants with advanced solid tumors To evaluate the immunogenicity of SYS6041 in participants with advanced solid tumors Exploratory objectives: To evaluate the correlation between FRα expression levels in tumor tissues and sFRα expression levels in peripheral blood and clinical efficacy/safety Cohort expansion phase Primary objectives: To evaluate the anti-tumor activity of SYS6041 in the treatment of advanced solid tumors at the RP2D dose Secondary objectives: To evaluate the anti-tumor activity of SYS6041 in advanced solid tumors To evaluate the safety and tolerability of SYS6041 in advanced solid tumors To evaluate the PK characteristics of SYS6041 in participants with advanced solid tumors To evaluate the immunogenicity of SYS6041 in participants with advanced solid tumors Exploratory objectives: To evaluate the correlation between FRα expression levels in tissue samples and sFRα expression levels in peripheral blood and clinical efficacy/safety

Start Date05 Mar 2025

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

100 Clinical Results associated with SYS6041

100 Translational Medicine associated with SYS6041

100 Patents (Medical) associated with SYS6041

100 Deals associated with SYS6041

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	China	CSPC Megalith Biopharmaceutial Co., Ltd.	05 Mar 2025
Neoplasms	Preclinical	China	CSPC Pharmaceutical Group Ltd.	30 Apr 2025

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