[Translation] A multicenter, open-label, Phase I clinical study evaluating the safety and tolerability, efficacy, PK, and immunogenicity of SYS6026 as a monotherapy or in combination with other drugs in the treatment of advanced solid tumors

本试验为一项多中心、开放、剂量探索和队列扩展的Ⅰ期临床研究，旨在评价SYS6026注射液不同接种方案治疗HPV16型或18型相关不可切除的局部晚期或转移性实体瘤参与者的安全性和免疫原性的基础上，进一步评价SYS6026联合恩朗苏拜单抗治疗HPV16型或18型相关不可切除的局部晚期或转移性实体瘤参与者的初步疗效。

[Translation]

This trial is a multicenter, open-label, dose-finding, and cohort-expansion Phase I clinical study designed to evaluate the safety and immunogenicity of different vaccination regimens of SYS6026 injection in the treatment of participants with HPV16- or 18-related unresectable locally advanced or metastatic solid tumors, and to further evaluate the preliminary efficacy of SYS6026 combined with enlangsubimab in the treatment of participants with HPV16- or 18-related unresectable locally advanced or metastatic solid tumors.

Start Date20 Oct 2025

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

CTR20244614

/ RecruitingPhase 1

评价SYS6026注射液在HPV16或18型相关高级别鳞状上皮内病变患者中的安全性和耐受性的I期临床试验

[Translation] A Phase I clinical trial to evaluate the safety and tolerability of SYS6026 injection in patients with HPV16 or 18-associated high-grade squamous intraepithelial lesions

本试验为一项多中心、剂量递增I期临床研究，旨在评价不同剂量的SYS6026注射液（以下简称“SYS6026”）治疗HPV16型或18型相关HSIL患者的安全性/耐受性、免疫原性、初步有效性和PK特征。

[Translation]

This trial is a multicenter, dose-escalation Phase I clinical study designed to evaluate the safety/tolerability, immunogenicity, preliminary efficacy and PK characteristics of different doses of SYS6026 injection (hereinafter referred to as "SYS6026") in the treatment of patients with HPV16 or 18-related HSIL.

Start Date08 Apr 2025

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

100 Clinical Results associated with SYS6026

100 Translational Medicine associated with SYS6026

100 Patents (Medical) associated with SYS6026

100 Deals associated with SYS6026

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.	20 Oct 2025
Human Papillomavirus-Related Cervical Intraepithelial Neoplasia	Phase 1	China	CSPC Megalith Biopharmaceutial Co., Ltd.	08 Apr 2025
HPV16 positive solid tumors	IND Approval	China	CSPC Megalith Biopharmaceutial Co., Ltd.	06 Aug 2025
HPV18 positive solid tumors	IND Approval	China	CSPC Megalith Biopharmaceutial Co., Ltd.	06 Aug 2025
Advanced Head and Neck Carcinoma	Preclinical	China	CSPC Pharmaceutical Group Ltd.	11 Sep 2023
Human Papillomavirus-Related Solid Tumors	Preclinical	China	CSPC Pharmaceutical Group Ltd.	11 Sep 2023
Uterine Cervical Cancer	Preclinical	China	CSPC Pharmaceutical Group Ltd.	11 Sep 2023

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