Clinical trials: sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumors
A Study of SYS6051 in Subjects With Advanced Solid Tumors
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…
- Trial name
- NCT07591285
- Testing
- SYS6051
- Volunteers
- 114 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
NSCLC
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC
This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC.
- Trial name
- SYNSTAR-02 (NCT07376382)
- Testing
- SYS6010, Osimertinib, platinum-pemetrexed
- Volunteers
- 680 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Urothelial Carcinoma
SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
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…
- Trial name
- NCT07526792
- Testing
- SYS6002, Investigator's Choice of Chemotherapy
- Volunteers
- 406 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Non-Small Cell Lung Cancer
SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ
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…
- Trial name
- SYNSTAR03 (NCT07442565)
- Testing
- SYS6010, Docetaxel
- Volunteers
- 506 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Locally Advanced/Metastatic/Recurrent ESCC
SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma
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…
- Trial name
- NCT07417735
- Testing
- SYS6010, Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)
- Volunteers
- 436 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced/Metastatic Solid Tumors
Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors
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…
- Trial name
- NCT07415863
- Testing
- SYS6043
- Where
- China
- Volunteers
- 820 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Recurrent or Metastatic Breast Cancer
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
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…
- Trial name
- NCT07406542
- Testing
- SYS6010, Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Urothelial Carcinoma
SYS6002 vs PADCEV in Patients With Advanced Urothelial 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…
- Trial name
- NCT07374549
- Testing
- SYS6002, enfortumab vedotin
- Volunteers
- 100 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Herpes Zoster
Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above
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.
- Trial name
- NCT07354659
- Testing
- A zoster mRNA vaccine SYS6017, Active Comparator Vaccine
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Non-Small Cell Lung Cancer
A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer
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.
- Trial name
- NCT07256509
- Testing
- SYS6010, Osimertinib, Pemetrexed
- Volunteers
- 120 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Esophageal Squamous Cell Carcinoma
A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.
This is a multicenter phase 2/3 clinical study to evaluate the efficacy and safety of SYS6010 plus SG001±5-FU/Capecitabine as first-line treatment, in patients with advanced/metastatic esophageal squamous cell carcinoma.
- Trial name
- NCT07251062
- Testing
- SYS6010+SG001+ physician's choice (Capecitabine or 5-FU), Investigator's choice of SOC, SYS6010+SG001
- Volunteers
- 737 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Cervical Cancer
SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
This study is a randomized, open-label, controlled, multicenter phase Ⅲ clinical trial, which aims to evaluate the efficacy and safety of SYS6002 versus investigator's choice of chemotherapy in the treatment of participants with…
- Trial name
- NCT07230626
- Testing
- SYS6002, Investigator's Choice of Chemotherapy
- Volunteers
- 412 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Head and Neck Squamous Cell Carcinoma
SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC
This is a Phase II study of anti-nectin-4 ADC combined with the EGFR monoclonal antibody and the PD-1 monoclonal antibody in participants with advanced head and neck squamous cell carcinoma.
- Trial name
- NCT06989671
- Testing
- JMT101, SYS6002, SG001
- Volunteers
- 430 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumors
Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study.
- Trial name
- NCT07122063
- Testing
- SYS6045
- Where
- China
- Volunteers
- 266 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumor
A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors
This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors.
- Trial name
- NCT07110883
- Testing
- SYS6023
- Where
- 2 sites in China
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
B-cell Malignancies, Solid Tumors
Evaluation of SYS6005 in Patients With Advanced Malignant Tumor
This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases.
- Trial name
- NCT06958679
- Testing
- SYS6005
- Where
- China
- Volunteers
- 132 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Small Cell Lung Cancer, Other Advanced Solid Tumors
A Study of SYS6040 for Injection in Patients 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…
- Trial name
- NCT06970795
- Testing
- SYS6040 for injection
- Where
- China
- Volunteers
- 180 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Herpes Zoster
Safety and Immunogenicity of SYS6017 in Healthy Participants Aged 40 Years or More
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.
- Trial name
- NCT06954818
- Testing
- A zoster mRNA vaccine SYS6017
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumors, Breast Cancer
Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors
The study consists of two phases. Phase 1b and Phase 2. Phase 1b aims to evaluate the safety, tolerability, and preliminary efficacy of SYS6010 as a monotherapy and in combination with SYH2051, and to determine the recommended…
- Trial name
- NCT06775236
- Testing
- SYS6010 jnjection, monotherapy chemotherapy, SYH2051 tablets
- Volunteers
- 410 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.