Clinical trials

To evaluate the safety and tolerability of SYH2092 Injection in healthy participants

This is an open-label, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of combination therapy with SYS6090 Injection in participants with hepatocellular carcinoma (HCC).

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with HNSCC.

This study constitutes an open-label, multi-cohort, multi-center Phase Ib/II clinical study, developed to assess the safety, tolerability, and therapeutic efficacy of SYS6090 injection when administered in combination with bevacizumab, or in triple combination with bevacizumab and chemotherapy, among patients diagnosed with advanced colorectal cancer.

This trial is the first-in-human study of SYS6041, a multicenter, open-label, dose-escalation, dose-reassignment and cohort-expansion Phase I/IIa clinical study, which aims to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary antitumor efficacy of SYS6041 in participants with advanced solid tumors.

This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.

This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer.

This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL).

This trial is a multicenter, open-label, dose exploration and cohort expansion Phase II clinical study designed to evaluate the safety, immunogenicity, and preliminary efficacy of different dosing regimens of SYS6026 injection (hereinafter referred to as "SYS6026") combined with Enlonstobart in patients with unresectable locally advanced or metastatic solid tumors associated with HPV types 16 or 18. The study consists of two phases: dose exploration and cohort expansion.

To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)

The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).

This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.

This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.

This study is a Phase Ib/II clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.

This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups: Test group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）

This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants with locally advanced or metastatic urothelial carcinoma. This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will commence only after formal approval is obtained from the relevant Ethics Committee).

This is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. The primary Objective is to evaluate the efficacy of SYS6010 versus docetaxel in participants with EGFR wild-type locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). Secondary Objectives includes safety, quality of life, immunogenicity, biomarkers, and efficacy correlations of SYS6010 compared to docetaxel in the same patient population.

This study is a randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Study of SYS6010 vs Investigator's Choice Single-Agent Chemotherapy in Locally Advanced/Metastatic/Recurrent ESCC Patients with Failure of At Least One Line of Systemic Therapy

Phase I/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors This study is a first-in-human phase I/II, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.

This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first- or second-line chemotherapy. It aims to compare the efficacy and safety of SYS6010 monotherapy versus investigator-selected chemotherapy.The study plans to enroll approximately 400 subjects, randomly assigned in a 1:1 ratio to the treatment arm and control arm(Investigator's choice of standard chemotherapy regimen, including eribulin, capecitabine, gemcitabine, or vinorelbine).

This study is a n open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma.

This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma. This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.

Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled "A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above".

To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.