A Phase III, Multicenter, Randomized, Double-Masked, Parallel Controlled, Non Inferior Study to Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection With Ranibizumab in Subjects With Wet Age-related Macular Degeneration (wAMD)

The purpose of this study is to compare the efficacy and safety of SCT510A versus Lucentis in the treatment of wet age-related macular degeneration.

Start Date14 Feb 2023

Sponsor / Collaborator

Sinocelltech Group Ltd.

CTR20221725 / TerminatedPhase 3

一项比较重组人源化抗VEGF单克隆抗体眼用注射液（SCT510A）和雷珠单抗注射液治疗湿性年龄相关性黄斑变性患者有效性、安全性的多中心、随机双盲、平行对照、非劣效III期临床研究

[Translation] A multicenter, randomized, double-blind, parallel-controlled, non-inferiority phase III clinical study comparing the efficacy and safety of recombinant humanized anti-VEGF monoclonal antibody ophthalmic injection (SCT510A) and ranibizumab injection in the treatment of patients with wet age-related macular degeneration

主要目的：比较SCT510A和雷珠单抗注射液治疗wAMD患者的有效性。次要目的：1、比较SCT510A和雷珠单抗注射液治疗wAMD患者的安全性。2、观察SCT510A在wAMD患者中的免疫原性。

[Translation]

Primary objective: To compare the effectiveness of SCT510A and ranibizumab injection in the treatment of wAMD patients. Secondary objectives: 1. To compare the safety of SCT510A and ranibizumab injection in the treatment of wAMD patients. 2. To observe the immunogenicity of SCT510A in wAMD patients.

Start Date10 Jan 2023

Sponsor / Collaborator

Shenzhou Cell Engineering Co. Ltd.

CTR20202027 / CompletedPhase 1/2

重组人源化抗VEGF单克隆抗体眼用注射液（SCT510A）多次给药治疗湿性年龄相关性黄斑变性的安全性、耐受性、药代动力学、有效性和药效学特征的多中心、开放Ⅰ/Ⅱ期临床研究

[Translation] A multicenter, open-label, phase I/II clinical study on the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of multiple-dose recombinant humanized anti-VEGF monoclonal antibody ophthalmic injection (SCT510A) in the treatment of wet age-related macular degeneration

评估SCT510A治疗wAMD的安全性和耐受性；观察SCT510A在wAMD受试者中的药代动力学、药效学和免疫原性特征；探索SCT510A在wAMD受试者中的疗效。

[Translation]

To evaluate the safety and tolerability of SCT510A in the treatment of wAMD; to observe the pharmacokinetic, pharmacodynamic, and immunogenicity characteristics of SCT510A in wAMD subjects; and to explore the efficacy of SCT510A in wAMD subjects.

Start Date06 Jan 2021

Sponsor / Collaborator

Shenzhou Cell Engineering Co. Ltd.

100 Clinical Results associated with Bevacizumab biosimilar(Sinocelltech Group)

100 Translational Medicine associated with Bevacizumab biosimilar(Sinocelltech Group)

100 Patents (Medical) associated with Bevacizumab biosimilar(Sinocelltech Group)

Literatures (Medical) associated with Bevacizumab biosimilar(Sinocelltech Group)

01 Nov 2024·Advances in Therapy

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

Article

Author: Xie, Liangzhi ; Chen, Rixin ; Li, Xingya ; Gai, Wenlin ; Liu, Lianke ; Zang, Kai ; Kong, Li ; Wang, Rui ; Luo, Hui ; Sun, Shenghua ; Ren, Tiejun ; Sun, Hongmei ; Huang, Zhe ; Jiang, Ou ; Chen, Weiqiu ; Li, Gaofeng ; Sun, Meili ; Yu, Yan ; Pan, Zhanyu ; Li, Wei ; Bian, Tao ; Hu, Chunhong ; Lei, Kaijian ; Wei, Zonghui ; Zhu, Bo ; Zhong, Fukuan ; Chen, Shaoshui ; Zhuang, Wu ; Lin, Dang ; Li, Runpu ; Cheng, Ying ; Hang, Xiaosheng ; Shi, Huaqiu ; Gu, Kangsheng ; Wu, Lin ; Sun, Debin ; Liu, Hailong ; Su, Huo ; Zhao, Li ; Lian, Juanwen ; Ren, Wenwen ; He, Miao

INTRODUCTIONSCT510 is a biosimilar to bevacizumab (Avastin) reference product (RP) that is approved for various metastatic cancers. In this study, we aimed to demonstrate the equivalence of SCT510 and bevacizumab in terms of efficacy, safety, immunogenicity and pharmacokinetics (PK) in patients with advanced non-squamous non-small cell lung cancer (NSCLC).METHODSPatients with non-squamous NSCLC were randomized equally to the SCT510 group (comprising SCT510, paclitaxel, and carboplatin) and the bevacizumab group (comprising bevacizumab, paclitaxel, and carboplatin) for 4-6 cycles, followed by maintenance monotherapy with SCT510. The primary endpoint was the objective response rate (ORR) at week 12. Secondary endpoints included 18-week ORR, disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and 1-year survival rate, as well as assessments of safety, immunogenicity, and multi-dose PK analysis.RESULTSBetween March 29, 2019, and April 27, 2021, 989 patients were screened and 567 eligible patients were randomly assigned to the SCT510 group (285 patients) and the bevacizumab group (282 patients). The ORR at week 12 was 52.6% [95% confidence interval (CI) 46.66-58.55%] in the SCT510 group and 52.5% (95% CI 46.47-58.47%) in the bevacizumab group. The ORR at week 18 was 55.4% (95% CI 49.46-61.30%) for SCT510 and 55.7% (95% CI 49.68-61.62%) for bevacizumab. The ORR risk ratio (RR) at weeks 12 and 18 was 0.99 (90% CI 0.873-1.133) and 0.99 (90% CI 0.872-1.114), respectively, both within the pre-specified equivalence margin of 0.75-1.33. There were no differences between the two groups in relation to other secondary endpoints, specifically DCR, DOR, PFS, OS, and 1-year survival rate. The overall safety findings were similar between the two treatment groups, and both SCT510 and bevacizumab RP exhibited low immunogenicity.CONCLUSIONSSCT510 is similar to bevacizumab in clinical efficacy, safety, immunogenicity, and PK in patients with advanced non-squamous NSCLC. The totality of the evidence supports the clinical equivalence of SCT510 and bevacizumab.TRIAL REGISTRATIONNCT03792074.

01 Jun 2023·Drugs in R&D

A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of SCT510 to Bevacizumab (Avastin^®) in Healthy Chinese Males.

Article

Author: Zhou, Huili ; Wu, Jing ; Zhang, Jingjing ; Shentu, Jianzhong ; Wu, Guolan ; Wu, Lihua ; Xie, Liangzhi ; Xu, Chang ; Lv, Duo

BACKGROUNDSCT510 is a recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), which is intended as a candidate biosimilar of bevacizumab that is approved for various metastatic cancers.Please confirm change in wording to match definition for VEGF belowYes.OBJECTIVEThis study aimed to compare the pharmacokinetics profiles, safety, and immunogenicity of SCT510 to bevacizumab (Avastin^®) in healthy Chinese males.METHODSThis was a single-center, double-blind, parallel-group phase I study. A total of 84 participants were randomly assigned (1:1) to receive a single 3 mg/kg infusion of either SCT510 or bevacizumab and followed up for 99 days. Primary endpoints were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC_0-∞), area under the serum concentration-time curve from time 0 to last quantifiable concentration (AUC_0-t), and the maximum observed concentration (C_max). Secondary endpoints included safety and immunogenicity.Kindly check and confirm the edit made in the article title.Yes.RESULTSA total of 82 subjects completed the study. Geometric means ratios (GMR) for AUC_0-∞, AUC_0-t, and C_max were 0.88, 0.89, and 0.97, respectively, for SCT510 versus bevacizumab (USA). The 90% confidence intervals for GMRs of AUC_0-∞, AUC_0-t, and C_max were all within the prespecified criteria (80-125%). No adverse events (AEs) led to study termination, and no serious adverse events (SAEs) were reported. None of the anti-drug antibodies (ADAs) identified were found to be neutralizing antibodies (NAbs), and only one subject from the SCT510 group tested positive for the ADA at the day 99 visit.CONCLUSIONThis study demonstrated that the pharmacokinetics, safety, and immunogenicity of SCT510 were equivalent to bevacizumab (Avastin^®). As a proposed biosimilar drug to bevacizumab, SCT510 was well tolerated in healthy Chinese males.CLINICAL TRIALS REGISTRATIONNCT05113511.

100 Deals associated with Bevacizumab biosimilar(Sinocelltech Group)

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	CN	Sinocelltech Group Ltd.	27 Jun 2023
Hepatocellular Carcinoma	CN	Sinocelltech Group Ltd.	27 Jun 2023
Metastatic Colorectal Carcinoma	CN	Sinocelltech Group Ltd.	27 Jun 2023
Non-squamous non-small cell lung cancer	CN	Sinocelltech Group Ltd.	27 Jun 2023
Ovarian Epithelial Carcinoma	CN	Sinocelltech Group Ltd.	27 Jun 2023
Primary peritoneal carcinoma	CN	Sinocelltech Group Ltd.	27 Jun 2023
Recurrent Glioblastoma	CN	Sinocelltech Group Ltd.	27 Jun 2023
Uterine Cervical Cancer	CN	Sinocelltech Group Ltd.	27 Jun 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Shenzhou Cell Engineering Co. Ltd.	08 Mar 2019
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	Shenzhou Cell Engineering Co. Ltd.	08 Mar 2019
Glioblastoma	Phase 3	US	Sinocelltech Group Ltd.	-
Kidney Neoplasms	Phase 3	CN	Sinocelltech Group Ltd.	-
Kidney Neoplasms	Phase 3	US	Sinocelltech Group Ltd.	-
Metastatic Colorectal Carcinoma	Phase 3	US	Sinocelltech Group Ltd.	-
Ovarian Cancer	Phase 3	US	Sinocelltech Group Ltd.	-
Uterine Cervical Cancer	Phase 3	US	Sinocelltech Group Ltd.	-
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 2	-	Sinocelltech Group Ltd.	01 Feb 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03792074 (Pubmed \| Adv Ther) Manual	Phase 3	Non-squamous non-small cell lung cancer Maintenance \| First line	567	SCT510+paclitaxel+carboplatin	(meuxikckmd) = ivfkbxndqu htmfbxtixc (vufzmglcqq, 46.66 - 58.55) View more	Similar	04 Sep 2024
				Bevacizumab+paclitaxel+carboplatin	(meuxikckmd) = pthysfthkx htmfbxtixc (vufzmglcqq, 46.47 - 58.47) View more
NCT04560894 (SCT-I10A, ASCO2024)	Phase 3	Advanced Hepatocellular Carcinoma First line alpha-fetoprotein level	346	SCT-I10A + SCT510	(rrzclxthom) = kagaitltqi sotcoizdjl (ltvjblfqke ) View more	Positive	24 May 2024
				Sorafenib	(rrzclxthom) = xkaciuwdqn sotcoizdjl (ltvjblfqke ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Bevacizumab biosimilar(Sinocelltech Group)

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation