Clinical trials: sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumors, Gastric Cancer (GC)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6062 in Patients With Advanced Solid Tumors.
This study is a multicenter, open-label, dose-escalation, PK expansion, and cohort expansion, first-in-human phase I/II study to evaluate the safety, tolerability, PK profile, and preliminary antitumor efficacy of SYS6062, a…
- Conditions
- Advanced Solid Tumors, Gastric Cancer (GC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- Trial name
- NCT07897227
- Testing
- SYS6062
- Volunteers
- 260 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Herpes Zoster
Immunogenicity and Safety of SYS6052 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
- NCT07892989
- Testing
- Recombinant Zoster Vaccine (CHO cell) SYS6052, Active Comparator Vaccine
- Volunteers
- 496 people, healthy volunteers welcome
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Head and Neck Squamous Cell Carcinoma
SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma
This study is an open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with immunotherapy in the recurrent or metastatic head and neck squamous cell carcinoma.
- Trial name
- NCT07254585
- Testing
- SYS6010 injection, Enlonstobart injection, Pembrolizumab injection
- Where
- China
- Volunteers
- 110 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Triple Negative Breast Cancer
A Study of SYS6043 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Recurrent or Metastatic Triple-Negative Breast Cancer
This is a randomized, controlled, open-label, multicenter study. Eligible participants are patients with unresectable locally recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic…
- Trial name
- NCT07879911
- Testing
- Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available. SYS6043, Investigator's Choice of Chemotherapy (paclitaxel，nab paclitaxel，capecitabine，eribulin，carboplatin）
- Volunteers
- 550 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced/Metastatic Solid Tumors
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6088 in Patients With Advanced/Metastatic Solid Tumors
This study is a multi-center, open-label, dose-escalation, dose-expansion, and cohort-expansion first-in-human Phase 1/2 study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of…
- Trial name
- NCT07857135
- Testing
- SYS6088, Regorafenib, Ivonescimab
- Volunteers
- 140 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Platinum-resistant Ovarian Cancer, Platinum-resistant Primary Peritoneal Cancer
A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancers
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…
- Conditions
- Platinum-resistant Ovarian Cancer, Platinum-resistant Primary Peritoneal Cancer, Platinum-resistant Fallopian Tube Cancer
- Trial name
- NCT07708753
- Testing
- SYS6043, Liposomal doxorubicin, paclitaxel, or topotecan
- Where
- China
- Volunteers
- 460 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumors
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of SYS6043 ± Bevacizumab ± Chemotherapy in Participants With Advanced Solid Tumors
This is a multicenter, open-label, safety run-in, dose-expansion and cohort-expansion Phase I/II study designed to evaluate the safety, tolerability, PK profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted…
- Trial name
- NCT07833735
- Testing
- SYS6043, bevacizumab, carboplatin
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Ovarian Cancer, Recurrent Ovarian Cancer
A Clinical Study of SYS6041 Combination Therapy for Recurrent Ovarian Cancer
This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.
- Trial name
- NCT07714668
- Testing
- SYS6041, bevacizumab, SYS6041, carboplatin, bevacizumab, paclitaxel, carboplatin, bevacizumab
- Where
- China
- Volunteers
- 171 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Overweight or Obesity
A Study of SYH2092 Injection in Healthy Participants
To evaluate the safety and tolerability of SYH2092 Injection in healthy participants
- Trial name
- NCT07776041
- Testing
- SYH2092 Injection
- Where
- Australia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
HCC - Hepatocellular Carcinoma
Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma
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).
- Trial name
- NCT07761286
- Testing
- SYS6090 Injection + Bevacizumab Injection, SYS6090 Injection +SYS6043 Injection +Bevacizumab Injection, Bevacizumab Injection + Sintilimab Injection
- Where
- China
- Volunteers
- 288 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Head and Neck Squamous Cell Carcinoma
SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC
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.
- Trial name
- NCT07758621
- Testing
- SYS6010, Investigator's Choice of monotherapy
- Volunteers
- 340 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Unresectable Advanced or Metastatic Colorectal Cancer
A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer
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…
- Trial name
- NCT07750041
- Testing
- SYS6090 (Fixed Dose Level A) + bevacizumab, SYS6090 (Fixed Dose Level B ) + bevacizumab, SYS6090 RP2D + bevacizumab +mFOLFOX6
- Where
- China
- Volunteers
- 260 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumors
A Phase I/IIa Study of SYS6041 in Patients With Advanced Solid Tumors
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…
- Trial name
- NCT07744763
- Testing
- SYS6041
- Where
- China
- Volunteers
- 260 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
High-grade Cervical Intraepithelial Lesions
A Phase II Clinical Trial Evaluating the Efficacy and Safety of SYS6026 Injection in Participants With HPV16 or 18-related High-grade Cervical Squamous Intraepithelial Lesions
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…
- Trial name
- NCT07702656
- Testing
- SYS6026
- Where
- China
- Volunteers
- 175 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Solid Tumor
A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics (PK), and Immunogenicity of the Combination Therapy of SYS6026 in the Treatment of Advanced Solid Tumors
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…
- Trial name
- NCT07684261
- Testing
- SYS6026 combined with Enlonstobart therapy
- Volunteers
- 186 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
EGFR-mutated Locally Advanced or Metastatic NSCLC
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）
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)
- Trial name
- NCT06927986
- Testing
- SYS6010, Pemetrexed, Cisplatin
- Where
- China
- Volunteers
- 380 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Non-small Cell Lung Cancer
A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in 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.
- Trial name
- NCT07672223
- Testing
- SYS6010, Enlonstobart, Tislelizumab
- Volunteers
- 570 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Breast Cancer
A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer
This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.
- Trial name
- NCT07597629
- Testing
- SYS6023, KN026
- Where
- China
- Volunteers
- 36 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Non-Small Cell Lung Cancer
SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNSTAR 04）
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…
- Trial name
- NCT07633873
- Testing
- SYS6010 injection, Enlonstobart injection, Tislelizumab injection
- Volunteers
- 500 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Advanced Solid Tumors
SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors
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…
- Trial name
- NCT07622225
- Testing
- SYS6006, Enlonstobart
- Volunteers
- 264 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.