An Open-lable, Multicenter Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6040 for Injection as a Single Agent in Participants With Advanced Solid Tumors

This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.

Start Date10 Apr 2025

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

CTR20251256

/ RecruitingPhase 1

评价注射用SYS6040单药在晚期实体瘤参与者中的安全性、耐受性、药代动力学特征及初步有效性的开放、多中心Ⅰ期临床研究

[Translation] An open, multicenter Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6040 for injection in participants with advanced solid tumors

Ia期剂量递增及回填阶段主要目的：1、评价注射用SYS6040的安全性和耐受性；2、确定注射用SYS6040的MTD和RP2D 次要目的：1、评价注射用SYS6040的药代动力学特征；2、评价注射用SYS6040的初步抗肿瘤活性；3、评估注射用SYS6040的免疫原性；4、评估肿瘤组织中的DLL3表达水平与临床疗效/安全性的相关性； Ib期队列扩展阶段主要目的：评价注射用SYS6040的初步抗肿瘤活性次要目的：1、评价注射用SYS6040的安全性和耐受性；2、评价注射用SYS6040的初步抗肿瘤活性；3、评价注射用SYS6040的药代动力学特征；4、评估注射用SYS6040的免疫原性；5、评估肿瘤组织中的DLL3表达水平与临床疗效/安全性的相关性

[Translation]

Phase Ia dose escalation and backfill phase Main objectives: 1. Evaluate the safety and tolerability of SYS6040 for injection; 2. Determine the MTD and RP2D of SYS6040 for injection Secondary objectives: 1. Evaluate the pharmacokinetic characteristics of SYS6040 for injection; 2. Evaluate the preliminary anti-tumor activity of SYS6040 for injection; 3. Evaluate the immunogenicity of SYS6040 for injection; 4. Evaluate the correlation between the expression level of DLL3 in tumor tissue and clinical efficacy/safety; Phase Ib cohort expansion phase Main objectives: Evaluate the preliminary anti-tumor activity of SYS6040 for injection Secondary objectives: 1. Evaluate the safety and tolerability of SYS6040 for injection; 2. Evaluate the preliminary anti-tumor activity of SYS6040 for injection; 3. Evaluate the pharmacokinetic characteristics of SYS6040 for injection; 4. Evaluate the immunogenicity of SYS6040 for injection; 5. Evaluate the correlation between the expression level of DLL3 in tumor tissue and clinical efficacy/safety

Start Date10 Apr 2025

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

100 Clinical Results associated with SYS6040

100 Translational Medicine associated with SYS6040

100 Patents (Medical) associated with SYS6040

100 Deals associated with SYS6040

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	China	CSPC Megalith Biopharmaceutial Co., Ltd.	10 Apr 2025
Small Cell Lung Cancer	Phase 1	China	CSPC Megalith Biopharmaceutial Co., Ltd.	10 Apr 2025

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