Wenlin Gai

Phase Ib Trial of Finotonlimab Combined With SCT200 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Jinguan Lin, Song Qu, Kunyu Yang, Tao Zhang et autres

BACKGROUND: Effective treatment options remain limited for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), including patients who have progressed after platinum-based chemotherapy and systemic-therapy-naïve patients. This Phase Ib trial evaluates the efficacy and safety of finotonlimab, …

cn (code pays fourni par la source)

Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial

Chuanhua Zhao, Yanqiao Zhang, Gang Wang, Jinfang Zheng et autres

We aimed to assess the tolerability and efficacy of finotonlimab (an anti-programmed cell death protein-1 antibody) in combination with SCT510, a bevacizumab biosimilar, versus sorafenib in unresectable advanced HCC. This randomized phase 2 and 3 study (ClinicalTrials.gov, NCT04560894; Chinadrugtrials.org.cn, CTR20201976 and CTR20201974) …

cn (code pays fourni par la source)

Phase Ib study of SCT200 combined with paclitaxel or docetaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma following platinum-based chemotherapy and PD-1 antibody

Jinguan Lin, Song Qu, Kunyu Yang, Tao Zhang et autres

cn (code pays fourni par la source)

Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study

Ying Cheng, Zhanyu Pan, Lin Wu, Bo Zhu et autres

cn (code pays fourni par la source)

Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial

Ruizhi Zhang, Junshi Zhao, Xiaoping Zhu, Qinghu Guan et autres

Evolution of SARS-CoV-2 variants emphasizes the need for multivalent vaccines capable of simultaneously targeting multiple strains. SCTV01E is a tetravalent COVID-19 vaccine derived from the spike protein of SARS-CoV-2 variants Alpha, Beta, Delta, and Omicron BA.1. In this double-blinded placebo-controlled pivotal efficacy …

cn (code pays fourni par la source)

Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial

Yuankai Shi, Wei Guo, Wei Wang, Yunteng Wu et autres

cn (code pays fourni par la source)

SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial.

Jianming Xu, Yanqiao Zhang, Gang Wang, Weiqing Chen et autres

4092 Background: Hepatocellular carcinoma (HCC) is a significant health concern in China, and it has been a leading cause of cancer-related deaths. Immunotherapy combined with anti-vascular growth therapy is the first recommended therapy. In this study, we evaluated the safety and efficacy …

cn (code pays fourni par la source)

Efficacy, safety and genomic analysis of SCT200, an anti-EGFR monoclonal antibody, in patients with fluorouracil, irinotecan and oxaliplatin refractory RAS and BRAF wild-type metastatic colorectal cancer: a phase Ⅱ study

Lin Yang, Wen Zhang, Nanfeng Fan, Peiguo Cao et autres

BACKGROUND: Limited therapeutic options are available for metastatic colorectal cancer (mCRC) patients after failure of first- and second-line therapies, representing an unmet medical need for novel therapies. METHODS: This is an open-label, single arm, multicenter, phase Ⅱ study aiming to perform the …

cn (code pays fourni par la source)

Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial

Suad Hannawi, Lixin Yan, Linda Saf Eldin, Alaa Abuquta et autres

Background: COVID-19 vaccines that offer broad-spectrum protection are needed. We aimed to evaluate the safety and immunogenicity of multivalent vaccines, SCTV01E and SCTV01C, and compare them with an inactivated vaccine. Methods: In the phase 3 trial (ClinicalTrials.gov: NCT05323461), adult participants previously vaccinated …

ae, cn (code pays fourni par la source)

Validation of Luminex immunological and competitive Luminex immunological assays for clinical immunogenicity assessment of a 14‐valent recombinant human papillomavirus vaccine

Xiao Zhang, Dan Meng, Hong Li, Xuefeng Li et autres

A novel virus-like particle (VLP)-based multivalent recombinant human papillomavirus (HPV) vaccine was developed and evaluated in human, including 14 HPV-type specific VLP antigens (HPV6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59). The pseudovirus-based neutralizing assay …

cn (code pays fourni par la source)

Safety, pharmacokinetics and efficacy of SCT200, an anti-EGFR monoclonal antibody in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer: a phase I dose-escalation and dose-expansion study

Wen Zhang, Xiaohong Han, Lin Yang, Yuanyuan Song et autres

Abstract Background An over-expression of the epidermal growth factor receptor (EGFR) has been observed in colorectal cancer and is associated with aggressive disease and poor prognosis. SCT200 is a newly developed recombinant, fully humanized, anti-EGFR monoclonal antibody. This study aimed to evaluate …

cn (code pays fourni par la source)

Comparison of efficacy and safety of ripertamab (SCT400) versus rituximab (Mabthera ® ) in combination with CHOP in patients with previously untreated CD20‐positive diffuse large B‐cell lymphoma: A randomized, single‐blind, phase III clinical trial

Yuankai Shi, Qingyuan Zhang, Xiaonan Hong, Zhen Wang et autres

Abstract This study compared the efficacy, safety and immunogenicity of ripertamab (SCT400) and rituximab (Mabthera ® ) combined with CHOP as the first‐line treatment for Chinese patients with CD20‐positive diffuse large B cell lymphoma (DLBCL). This is a randomized, patient‐blind, multicenter, active‐control, …

cn, hk (code pays fourni par la source)