The Efficacy and Safety of IBI351 Plus Cetuximab β in Untreated, Locally Advanced or Metastatic Non-small Cell Lung Cancer With KRAS G12C Mutation: A Single-arm, Prospective, Multicenter Phase II Clinical Study

Study Design: a Phase II, single-arm, multicenter, prospective, interventional study.
Target Population: Subjects with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to harbor the KRAS G12C mutation.
Treatment Regimen: All enrolled subjects will receive IBI351 combined with cetuximab β injection. Treatment will continue until disease progression (as assessed by the investigator per RECIST 1.1 criteria) or the occurrence of intolerable toxicity.
Primary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Secondary Endpoints: Disease Control Rate (DCR), Time to Response (TTR), Progression-Free Survival (PFS), and Overall Survival (OS) , and safety.

开始日期2025-09-01

申办/合作机构

信达生物制药（苏州）有限公司

[+1]

CTR20170701

/ Active, not recruiting临床3期

重组抗EGFR人鼠嵌合单抗一线治疗RAS/BRAF基因野生型转移性结直肠癌III期临床试验

以FOLFIRI化疗方案为对照，评价CMAB009联合FOLFIRI化疗方案作为一线用药，治疗RAS/BRAF基因野生型、转移性结直肠癌患者的有效性与安全性。

开始日期2018-01-19

申办/合作机构

上海张江生物技术有限公司

NCT03206151

/ Completed临床3期

Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Giving combination chemotherapy together with CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer（first-line treatment）may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with CMAB009 is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in combination with a standard and effective chemotherapy FOLFIRI（5-Fluorouracil /Folinic acid plus Irinotecan）for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.

开始日期2017-12-12

申办/合作机构

泰州迈博太科药业有限公司

100 项与西妥昔单抗生物类似药 (张江生物) 相关的临床结果

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100 项与西妥昔单抗生物类似药 (张江生物) 相关的专利（医药）

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项与西妥昔单抗生物类似药 (张江生物) 相关的文献（医药）

2024-04-01·Journal of pharmaceutical and biomedical analysis

Highly drug/target-tolerant neutralizing antibody (NAb) assay development through target-based drug depletion and drug-based NAb extraction for an anti-EGFR therapeutic monoclonal antibody

Article

作者: Zhao, Xiang ; Su, Xinyi ; Wang, Fugui ; Xu, Jin ; Li, Jun ; Guo, Qingcheng ; Ji, Lusha ; Fu, Rongrong ; Qian, Weizhu ; Guo, Huaizu ; Liu, Tao ; Zhang, Dapeng ; Xu, Mengjiao ; Hou, Sheng

The reduction of immunogenicity is fundamental for the development of biobetter Erbitux, given that the development of an immune response reduces treatment efficacy and may lead to potential side effects. One of the requirements for the clinical research of a Erbitux biobetter candidate (CMAB009) is to develop a neutralizing antibody (NAb) assay, and sufficient drug and target tolerance for the assay is necessary. Here, we describe the development of a competitive ligand binding (CLB) assay for CMAB009 with high drug and target tolerance through target-based drug depletion and drug-based NAb extraction, the integrated experimental strategy was implemented to simultaneously mitigate drug interference and enhance target tolerance. Following troubleshooting and optimization, the NAb assay was validated for clinical sample analysis with the sensitivity of 92 ng/mL, drug tolerance of 70 μg/mL and target tolerance of 798 ng/mL. The innovative drug depletion and NAb extraction achieved though the combination of drug and target beads would enable the development of reliable NAb assays for many other therapeutics that overcome drug and its target interference for more precise and sensitive NAb assessment.

2019-12-01·Cancer communications (London, England)1区 · 医学

CMAB009 plus irinotecan versus irinotecan‐only as second‐line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild‐type metastatic colorectal cancer patients: promising findings from a prospective, open‐label, randomized, phase III trial

1区 · 医学

ArticleOA

作者: Bi, Feng ; Hu, Xiaohua ; Wang, Liwei ; Ouyang, Xuenong ; Cheng, Ying ; Shi, Yuankai ; Sun, Yan ; He, Xiaohui ; Chen, Yigui ; Sun, Guoping ; Wang, Zhehai ; Liu, Wei ; Li, Yuhong ; Yao, Qiang ; Li, Jin ; Zheng, Rongsheng ; Zhang, Yiping ; Bai, Li ; Luo, Yi ; Liu, Yunpeng ; Qin, Shukui ; Xu, Jianming

Abstract:

Background:

The 5‐fluorouracil/leucovorin plus oxaliplatin (FOLFOX) regimen is the standard first‐line treatment for metastatic colorectal cancer (mCRC), however, the optimal second‐line regimen for KRAS wild‐type mCRC patients is still investigational. In this study, we aimed to determine the clinical efficacy and safety of CMAB009 plus irinotecan compared to irinotecan‐only as a second‐line regimen for treating KRAS wild‐type mCRC patients.

Methods:

Patients with KRAS wild‐type mCRC who had previously failed to respond to FOLFOX treatment were randomly assigned in a 2:1 ratio, to receive CMAB009 plus irinotecan or irinotecan‐only. Patients receiving irinotecan‐only were permitted to switch to CMAB009 therapy on disease progression and were grouped as the sequential‐CMAB009 arm. The primary endpoints were overall response rate (ORR) and median progression‐free survival (PFS). The secondary endpoints were median overall survival (OS), disease control rate (DCR), clinical benefit rate (CBR), and duration of response (DOR).

Results:

The CMAB009 plus irinotecan arm demonstrated significantly improved ORR (33.2% vs. 12.8%; P < 0.001) and longer median PFS (169 days vs. 95 days; P < 0.001) as compared to the irinotecan‐only arm. Patients receiving CMAB009 plus irinotecan also demonstrated improved DCR (80.1% vs. 65.2%, P < 0.001), CBR (30.0% vs. 14.6%, P < 0.001), and DOR (210 days vs. 109 days; P< 0.001) as compared to irinotecan‐only. However, patients treated with CMAB009 had an increased risk of skin rash (66.9% vs. 5.5%, P < 0.001) and paronychia (9.8% vs. 0.0%, P < 0.001). Anti‐drug antibodies (ADA) were detected in 3.6% of patients, and only 0.9% of patients who received CMAB009 experienced hypersensitivity reactions. In patients receiving sequential‐CMAB009 therapy after failure with irinotecan, their median PFS was 84 days (95% CI 65 to 113 days). The median OS was 425 days for patients receiving CMAB009 plus irinotecan and 401 days for those with sequential‐CMAB009 (P= 0.940).

Conclusions:

Treatment with CMAB009 plus irinotecan was found to be a superior second‐line regimen in comparison to irinotecan‐only in KRAS wild‐type mCRC patients. Further, switching to CMAB009 can be considered as an efficient third‐line of treatment after treatment failure with second‐line irinotecan‐only.Trial registrationClinicalTrials.gov: NCT01550055, retrospectively registered on March 9, 2012.

2015-01-02·Acta oncologica (Stockholm, Sweden)2区 · 医学

Dose intensified hypofractionated intensity-modulated radiotherapy with synchronous cetuximab for intermediate stage head and neck squamous cell carcinoma

2区 · 医学

Article

作者: Ashcroft, Linda ; Ho, Kean F. ; Garcez, Kate ; Slevin, Nicholas J. ; Yap, Beng K. ; Thomson, David J. ; Mais, Kathleen L. ; Denton, Kim ; Sykes, Andrew J. ; Rowbottom, Carl G. ; Lee, Lip W. ; Betts, Guy

BACKGROUND:

For stage II and III head and neck squamous cell carcinoma (HNSCC) treated with radiotherapy alone, loco-regional recurrence is the main cause of treatment failure. Strategies to improve loco-regional control should not be at the expense of increased late normal tissue toxicity. We investigated dose-intensified hypofractionated intensity-modulated radiotherapy (IMRT) with synchronous cetuximab.

MATERIAL AND METHODS:

In a phase I/II trial, 27 patients with stage III or high risk stage II HNSCC were recruited. They received three dose level simultaneous integrated boost IMRT, 62.5 Gy in 25 daily fractions to planning target volume one over five weeks with synchronous cetuximab. The primary endpoint was acute toxicity. Secondary endpoints included: late toxicity and quality of life; loco-regional control, cause-specific and overall survival.

RESULTS:

Radiotherapy was completed by 26/27 patients; for one (4%) the final fraction was omitted due to skin toxicity. All cycles of cetuximab were received by 23/27 patients. Grade 3 acute toxicities included: pain (81%), oral mucositis (78%) and dysphagia (41%). There were few grade 3 physician-recorded late toxicities, including: pain (11%), problems with teeth (8%) and weight loss (4%). At 12 months, only one (4%) patient required a feeding tube, inserted prior to treatment due to dysphagia. The maximal/peak rates of patient-reported late toxicities included: severe pain (11%), any dry mouth (89%) and swallowing dysfunction that required a soft/liquid diet (23%). At 12 months, all quality of life and most symptoms mean scores had resolved to baseline or were only a little worse; dry mouth, sticky saliva and dentition scores remained very much worse. At a median follow-up of 47 months, there were five (18.5%) loco-regional recurrences and the overall cause-specific survival was 79% (95% CI 53-92).

CONCLUSIONS:

This regimen is safe with acceptable acute toxicity, low rates of late toxicity and impact on quality of life at 12 months following treatment. Further evaluation is recommended.

项与西妥昔单抗生物类似药 (张江生物) 相关的新闻（医药）

2025-11-05

·先声药业

SIM0237膀胱癌I期数据亮相2025国际泌尿外科学会年会口头报告

2025年10月29日-11月1日，第45届国际泌尿外科学会年会（SIU2025）在英国爱丁堡举行。先声药业集团旗下先声再明医药有限公司自主研发的PD-L1/IL-15双功能融合蛋白SIM0237用于非肌层浸润性膀胱癌（NMIBC）治疗的I期临床研究数据亮相大会口头报告。该研究的单药剂量递增阶段展现出良好的安全性、耐受性与抗肿瘤活性，引发国际泌尿医学界广泛关注。膀胱癌是常见的恶性肿瘤之一，其中非肌层浸润性膀胱癌(NMIBC)约占初诊患者的75%。NMIBC的主要治疗手段为局部手术切除及术后膀胱灌注化疗或卡介苗（BCG）治疗等，但依然存在较高的复发及进展风险。对于BCG无应答的NMIBC患者，目前标准治疗仍为根治性膀胱切除术，手术风险较高，并对患者生活质量有显著影响。 SIM0237是先声再明自主研发的PD-L1单抗与减活IL-15/IL-15Rα sushi融合蛋白。该分子通过结合PD-L1，阻断PD-1/PD-L1免疫抑制通路，同时通过IL-15激活免疫系统，发挥双功能协同抗肿瘤作用。SIM0237的IL-15端经过减活改造，可增加耐受性与暴露量。临床前研究显示，SIM0237在人膀胱癌异种移植模型中表现出显著的抗肿瘤活性。 SIM0237-102是一项开放标签、多中心I/II期研究。其单药剂量递增阶段纳入了17名对卡介苗无应答的高危NMIBC患者。三个剂量水平均显示出令人鼓舞的抗肿瘤活性：所有3名原位癌患者均达到完全缓解（CR），其中2名患者的CR状态到数据截止日期已分别维持6个月和12个月。另14名T1或高级别Ta期乳头状肿瘤患者中，中位无病生存期（DFS）尚未成熟，12个月DFS率为69.2%（95% CI, 37.3%-87.2%）。安全性方面，膀胱内灌注SIM0237在所有3个剂量水平均表现出良好的安全性特征，未出现任何剂量限制性毒性、药物相关严重不良事件或3级及以上药物相关不良事件。300毫克剂量被选为SIM0237单药治疗的推荐剂量。 SIM0237单药治疗NMIBC的剂量扩展部分以及SIM0237联合BCG的剂量递增部分正在进行中。单药剂量扩展部分结果提示SIM0237有望成为NMIBC的新型疗法，相关数据将于明年国际学术会议进一步披露。先声再明是先声药业集团旗下专注于肿瘤领域的生物医药公司，致力于以突破性治疗手段, 解决全球肿瘤领域巨大的未满足临床需求。先声再明已在中国成功推出多款创新产品，包含恩泽舒®、科赛拉®、恩维达®、恩度®、恩立妥®。先声再明以自主研发，与合作伙伴协同创新，为全球肿瘤患者提供潜在的变革性治疗方案。媒体联络：pr@zaiming.com 编辑 | 李逸玲审校 | 吴涛审核 | 汪咏钰

临床1期临床结果

2025-10-16

·先声药业

先声再明新型ADC候选药物SIM0505完成Ⅰ期临床美国首例患者入组

• 首例美国患者已完成给药，已有剂量组已观察到多重应答； • 多区域试验将加速概念验证，预计于2026年上半年获得数据。中国上海/美国马里兰州贝尔茨维尔，2025年10月16日——先声药业集团（2096.HK）旗下的抗肿瘤创新药公司先声再明与致力于癌症创新药开发的临床阶段美国生物制药公司NextCure, Inc.（Nasdaq：NXTC）今日宣布，SIM0505用于晚期实体瘤患者的Ⅰ期临床试验（NCT06792552）已完成首例美国患者给药。研究旨在评估该药物的安全性、耐受性、药代动力学及疗效。 SIM0505是由先声再明研发的一款靶向CDH6（钙粘蛋白-6或K-钙粘蛋白）的新型ADC。其独特的结合表位对肿瘤抗原的亲和力高于同类候选药物。SIM0505还采用了先声再明专有的TOPO异构酶1抑制剂(TOPOi)有效载荷，在具备强抗肿瘤活性的同时，也有较高的系统清除率，从而扩大治疗窗口。其Ⅰ期剂量递增研究在中国启动后，由NextCure扩展至美国，于中剂量组开始纳入美国患者，此后将在中美两国持续推进。NextCure已获得先声再明SIM0505在大中华区以外的全球独家许可。 NextCure首席医疗官Udayan Guha博士表示："我们对合作伙伴取得的重大进展感到欣慰，这使得我们能够以接近潜在临床推荐的剂量水平启动美国患者入组。根据现有数据，SIM0505的耐受性与安全性特征良好，相信其有潜力成为CDH6领域的领先疗法，期待加速推进当前试验并在2026年上半年得到概念验证数据。" 先声再明首席医学官汪咏钰博士表示："美国首例患者入组是SIM0505全球临床开发的重要里程碑。这标志着我们为中国及全球患者推进创新肿瘤治疗的又一重要步伐。" 先声再明是先声药业集团旗下专注于肿瘤领域的生物医药公司，致力于以突破性治疗手段, 解决全球肿瘤领域巨大的未满足临床需求。先声再明已在中国成功推出多款创新产品，包含恩泽舒®、科赛拉®、恩维达®、恩度®、恩立妥®。先声再明以自主研发，与合作伙伴协同创新，为全球肿瘤患者提供潜在的变革性治疗方案。媒体联络：pr@zaiming.com NextCure是美国一家临床阶段的生物制药公司，致力于通过采用具有差异化作用机制，包括抗体偶联药物开发创新疗法，用以治疗对现有疗法无反应或病情进展的癌症患者。NextCure专注于推进能够发挥其核心优势的疗法，这些优势包括对生物通路与生物标志物的深入理解、对细胞相互作用（包括肿瘤微环境中的相互作用）的研究，以及探索将这些相互作用转化为创新性治疗手段。http://www.nextcure.com 编辑 | 李逸玲审校 | 覃小恒审核 | 汪咏钰

临床1期抗体药物偶联物临床2期突破性疗法

2025-09-27

·先声药业

先声再明ADC药物SIM0609获FDA批准在美国进入临床研究

2025年9月28日，先声药业集团（2096.HK）旗下抗肿瘤创新药公司先声再明宣布，其自主研发的抗肿瘤候选药物——靶向CDH17的抗体偶联药物（ADC）SIM0609已获得美国食品药品监督管理局（FDA）批准开展临床试验，用于治疗晚期实体瘤。 SIM0609是一款靶向钙黏蛋白17（CDH17）的新型抗体偶联药物，由一种人源化单克隆抗体通过本集团专有的新型水溶性可裂解连接子，与先声再明自主研发的新型拓扑异构酶I（ TOP-I）抑制剂偶联而成。CDH17在多种癌症中高度表达，包括结直肠癌、胃癌、胰腺癌等，具有作为晚期实体瘤，尤其是消化道肿瘤治疗靶点的潜力。该项目已于2025年9月8日获得中国IND批件。先声再明是先声药业集团旗下专注于肿瘤领域的生物医药公司，致力于以突破性治疗手段, 解决全球肿瘤领域巨大的未满足临床需求。先声再明已在中国成功推出多款创新产品，包含恩泽舒®、科赛拉®、恩维达®、恩度®、恩立妥®。先声再明以自主研发，与合作伙伴协同创新，为全球肿瘤患者提供潜在的变革性治疗方案。媒体联络：pr@zaiming.com 编辑 | 李逸玲审校 | 杨晨审核 | 汪咏钰

抗体药物偶联物临床申请临床研究

100 项与西妥昔单抗生物类似药 (张江生物) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC06	-

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适应症	国家/地区	公司	日期
RAS/BRAF基因野生型结直肠癌	中国	泰州迈博太科药业有限公司	2024-06-18

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适应症	最高研发状态	国家/地区	公司	日期
KRAS 野生型结直肠癌	临床3期	-	上海张江生物技术有限公司	2009-05-31
转移性结直肠癌	临床3期	-	上海张江生物技术有限公司	2009-05-31

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03206151 (NEWS \| Pubmed) 人工标引	临床3期	RAS/BRAF基因野生型结直肠癌 RAS/BRAF野生型	505	CMAB009 + FOLFIRI	蓋顧築淵鬱鬱積鏇製齋(襯範糧鏇衊襯醖顧選窪) = 遞鏇窪鏇蓋壓顧齋糧憲鹽齋鏇襯醖遞範積膚製 (衊簾鹽鏇壓簾窪淵鹹醖 ) 更多	积极	2025-05-09
				FOLFIRI	蓋顧築淵鬱鬱積鏇製齋(襯範糧鏇衊襯醖顧選窪) = 選願鹹觸繭淵餘繭製壓鹽齋鏇襯醖遞範積膚製 (衊簾鹽鏇壓簾窪淵鹹醖 ) 更多
NCT01550055 (CRC009, Pubmed \| Cancer Commun (Lond)) 人工标引	临床3期	KRAS 野生型结直肠癌二线 KRAS Wild-type	1,077	irinotecan+CMAB009	淵壓壓築夢鹽鹽製構艱(蓋鑰觸淵餘願願鹽繭築) = 範顧製願夢製襯繭憲鬱膚鬱憲鹽餘醖襯衊餘網 (範範鹽蓋壓餘築鏇簾鏇 ) 更多	优效	2019-05-24
				irinotecan	淵壓壓築夢鹽鹽製構艱(蓋鑰觸淵餘願願鹽繭築) = 膚醖淵廠顧觸衊糧築壓膚鬱憲鹽餘醖襯衊餘網 (範範鹽蓋壓餘築鏇簾鏇 ) 更多
NCT01550055 (ZJBIO009, ASCO2017)	临床3期	KRAS 野生型结直肠癌 \| 转移性结直肠癌二线	512	CMAB009 plus irinotecan	壓鑰廠夢願衊糧醖襯夢(鏇簾顧願艱廠膚淵艱積) = 製願蓋構膚獵艱窪願鬱夢顧廠憲膚積糧遞鹹膚 (鏇願顧築選餘積淵窪鹹 ) 更多	积极	2017-05-30
				Irinotecan alone	壓鑰廠夢願衊糧醖襯夢(鏇簾顧願艱廠膚淵艱積) = 夢夢遞艱遞鏇淵構繭鑰夢顧廠憲膚積糧遞鹹膚 (鏇願顧築選餘積淵窪鹹 ) 更多
Pubmed \| Acta Oncol	临床1/2期	头颈部鳞状细胞癌	27	Dose-intensified hypofractionated intensity-modulated radiotherapy with synchronous cetuximab	醖積積餘鹹膚壓選鑰製(襯糧廠選觸顧鏇鬱窪簾) = 壓鹹鹹衊鑰網齋襯餘簾餘觸築鬱餘壓廠觸鹹醖 (齋糧鬱簾淵願窪醖鑰製, 53 ~ 92)	-	2015-01-02