重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）(Erfonrilimab) - 药物靶点：CTLA4 x PDL1_在研适应症：HER2阳性胃食管交界处癌，晚期胰腺导管腺癌，鳞状非小细胞肺癌_专利_临床

概要

基本信息

药物类型

双特异性抗体

别名

Recombinant Humanized PDL1/CTLA-4 Bispecific Domain Antibody Fc Fusion Protein、重组人源化PD-L1/CTLA4双特异性单域抗体Fc融合蛋白、KN 046

+ [1]

靶点

CTLA4 x PDL1

作用机制

CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂)、PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [4]

在研适应症

HER2阳性胃食管交界处癌晚期胰腺导管腺癌鳞状非小细胞肺癌+ [11]

非在研适应症

晚期食管鳞状细胞癌晚期肝细胞癌晚期非小细胞肺癌+ [10]

原研机构

苏州康宁杰瑞生物科技有限公司

在研机构

江苏康宁杰瑞生物制药有限公司北京市肿瘤防治研究所

苏州开拓药业股份有限公司

+ [1]

非在研机构

苏州泽璟生物制药股份有限公司浙江瑞臻医药有限公司Alphamab Australia Co. Pty Ltd.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评孤儿药 (美国)、特殊审批 (中国)

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结构/序列

Sequence Code 453187443H

来源: *****

关联

46

项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的临床试验

NCT05832892

/ Recruiting临床1/2期IIT

A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Surufatinib in Combination With KN046 and AG Regimen Chemotherapy for the First-Line Treatment of Unresectable Advanced Pancreatic Cancer

Advanced pancreatic cancer is a highly aggressive and fatal disease with an extremely low 5-year survival rate. Combined chemotherapy is the mainstay of treatment for patients with unresectable advanced pancreatic cancer, and the combination of nab-paclitaxel and gemcitabine (AG regimen) has been one of the most commonly used regimens for more than a decade. However, chemo-resistance often occurs within half a year and the efficacy remains unsatisfied with an overall survival of only 9
11 months.
Immune checkpoint inhibitors (ICIs) such as anti-PD-1/L1 antibody and anti-CTLA-4 antibody have demonstrated encouraging anti-tumor efficacy in multiple solid tumors including lung cancer, gastric cancer, and esophageal cancer, while obtained controversial results when combined with chemotherapy in pancreatic cancer. Recently, the immune-suppression tumor microenvironment (TME) of pancreatic cancer has been described in several pre-clinical studies, which may explain the resistance against ICIs and chemotherapy.
KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific antibody with innovative designs include a proprietary CTLA-4 domain antibody with a significantly improved safety profile, a bispecific antibody fused with PD-L1 antibody targeting the TME with high PD-L1 expression. Recent clinical studies have shown promising anti-tumor activity of KN046 in pancreatic cancer.
Surufatinib, also known as HMPL-012 or Sulfatinib, is a small molecular tyrosine kinase inhibitor (TKI) targeting the Vascular Endothelial Growth Factor Receptor (VEGFR), Fibroblast Growth Factor Receptor (FGFR) and Colony Stimulating Factor-1 Receptor (CSF-1R), which has a dual mechanism of action of anti-angiogenesis and regulation of immune microenvironment. Previous studies have suggested synergic effect of surufatinib in combination with anti-PD-1 antibodies.
This phase Ib/II clinical trial is intended to investigate the activity and safety of the combination of surufatinib combined with KN046 and the AG regimen chemotherapy as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer.

开始日期2023-11-01

申办/合作机构

复旦大学附属中山医院

[+1]

NCT05985109

/ Recruiting临床2期IIT

A Phase II Multi-cohort Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib for Metastatic Microsatellite-Stable Colorectal Cancer: a Phase II Multi-cohort Study

The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.

开始日期2023-10-26

申办/合作机构

北京市肿瘤防治研究所

NCT06099821

/ Recruiting临床2期IIT

A Phase II Clinical Study Evaluating The Efficacy and Safety of KN046 in Combination With Regorafenib or Apatinib for Microsatellite Instability-High Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.

开始日期2023-10-25

申办/合作机构

北京肿瘤医院（北京大学肿瘤医院）

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的临床结果

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100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的转化医学

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100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的专利（医药）

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17

项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-07-01·CANCER TREATMENT REVIEWS

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Review

作者: Jiménez-Labaig, Pablo ; Braña, Irene ; Hernando-Calvo, Alberto ; Harrington, Kevin J ; Bhide, Shreerang ; Rullan, Antonio ; O'Leary, Ben ; Llop, Sandra

INTRODUCTION:

There is a need to improve the outcomes of patients with head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC), especially in recurrent unresectable and metastatic (R/M) setting. Antibody-drug conjugates (ADC) and bispecific antibodies (BsAb) may deliver promising results.

METHODS:

We conducted a systematic literature review to identify ADC and BsAb clinical trials, involving patients with HNSCC and NPC, from database creation to December 2023. We reported trial characteristics, overall response rate (ORR), overall survival (OS), and grade ≥ 3 treatment-related adverse events (trAEs).

RESULTS:

23 trials (65 % phase I) were found, involving 540 R/M patients (355 [20trials] HNSCC and 185 [5trials] NPC). There were 13 ADC (n = 343) and 10 BsAb (n = 197) trials. 96 % patients were refractory to standard of care treatments. ORR ranged from 0 to 100 %, with the highest ORR for GEN1042 plus chemoimmunotherapy. ORRs for monotherapies were 47 % for ADC, and 0-37 % for BsAb. MRG003 reached in HNSCC 43 % and NPC 47 %. BL-B01D1 54 % in NPC. Longest median OS was seen with MRG003 and KN046. Grade ≥ 3 trAEs were 28-60 % in ADC trials, and 3-33 % BsAb. Grade ≥ 3 myelosuppressive trAEs were typically seen in 8 ADC trials, while 4 BsAb showed infusion-related reactions (IRR). Four treatment-related deaths were reported (1 pneumonitis), all ADC trials.

CONCLUSION:

ADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting.

176

项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的新闻（医药）

2025-02-18

·癌度

堪比靶向药，芦比替定联合PD-1治疗复发性小细胞肺癌可期待！

小细胞肺癌是恶性程度最高的肺癌亚型，大概占到肺癌的15%左右，尽管大多数小细胞肺癌对铂类和依托泊苷治疗有效，但是最初的一线治疗效果并不会很长久，确诊为小细胞肺癌的患者5年生存率不到3%，所以在一线治疗之后的二线治疗一直是被关注的焦点。目前的二线治疗总体应答率仅为20%，患者生存期延长的极为有限。尽管免疫检查点抑制剂在很多肿瘤类型获得了突破，在小细胞肺癌的治疗里免疫治疗不是那么顺利。最近PD-1抑制剂纳武利尤单抗和帕博利珠单抗被撤销小细胞肺癌的适应症，也就是这两个药物三线治疗小细胞肺癌是不合规的。下面癌度给大家编译的是免疫治疗联合其他药物的探索，是将芦比替定与PD-1抑制剂组合二线治疗小细胞肺癌。相关的研究结果刊登在国际学术期刊。 1、芦比替定联合PD-1二线治疗小细胞肺癌芦比替定这个药物的治疗机制比较复杂，在一项二期临床试验中芦比替定单药二线治疗广泛期小细胞肺癌（剂量是每平方体表面积用药3.2毫克），治疗应答率达到了35.2%，中位无进展生存时间达到了3.4个月，这个药物在欧盟和美国被批准了小细胞肺癌的二线适应症。而我们将给大家介绍的是芦比替定与PD-1抑制剂帕博利珠单抗的联合，PD-1用药是三周一个周期的200毫克剂量。临床研究的相关结果这是一项比较早期的临床试验，广泛期小细胞肺癌一线治疗耐药之后被招募入组，根据一线铂类化疗后病情进展时间分为两组，如果铂类化疗后进展时间大于90天就是铂类敏感，如果小于90天则是铂类耐药。上面的图示给出了相关的治疗数据。所有入组患者的治疗应答率为46.4%，3名患者可评估肿瘤病灶完全消失，也就是完全缓解，40%的患者缓解持续时间大于12个月，中位无进展生存时间为4.6个月，中位总生存时间是10.5个月。患者对治疗的应答情况铂类敏感患者的中位无进展生存时间达到了8个月，如果是铂类耐药患者则中位无进展生存时间是2.8个月。两组患者的中位总生存时间也有差别，分别是15.7个月和7.1个月。联合用药最为常见的不良反应是短暂性中性粒细胞减少症。 2、值得参考的疗效数据从上面的疗效数据来说，芦比替定联合PD-1是值得参考的，尤其是铂类敏感患者的中位无进展生存时间达到了8个月，这个疗效跟靶向药相比是不差的。但是需要注意芦比替定的用药剂量，如果是每平方米2毫克的剂量可能就不一定达到这样的效果，大家可以比较系统的参考本文下面的参考文献阅读。另外大家也可以关注这个组合用药的临床试验，如果有机会可以免费用药则是最好的选择。癌度与吉因加启动的“基因检测人人可及”计划里，仅需要3000元就能检测36个基因，大家可以联系癌度或扫描上面的二维码咨询癌度医学顾问，了解基因检测的相关问题。参考出处： Calles A,et al., Lurbinectedin plus pembrolizumab in relapsed small cell lung cancer (SCLC): the phase I/II LUPER study, Journal of Thoracic Oncology (2025). 往期推荐 1230名非小细胞肺癌的治疗经验，62.1%可以靶向治疗，21.7%的患者可以免疫治疗！第二代NTRK靶向药BPI-28592，靶向药耐药后仍能让全部病灶消失! 免疫药物PD-1入不入脑？驱动基因阴性脑转移肺癌的最佳治疗策略是什么？双特异性免疫药物KN046联合仑伐替尼治疗肝细胞癌，治疗应答率和生存期数据亮眼！

临床结果免疫疗法临床2期

2025-02-13

·癌度

第二代NTRK靶向药BPI-28592，靶向药耐药后仍能让全部病灶消失!

抗癌的药物的开发一般是需要找到关键的靶向目标，比如肺癌的EGFR或ALK，因为很多的非小细胞肺癌存在这些基因突变，所以针对性对这些基因突变开发靶向药。NTRK也是一种驱动基因，尽管这种驱动基因的突变概率不是很高，但是在多种实体瘤都可能存在NTRK基因突变，而且针对NTRK融合基因突变也批准了靶向药。需要注意是NTRK与其他基因发生融合才属于驱动型基因突变，如果是NTRK发生了点突变，这往往并不是驱动型基因突变，也大概率不能从靶向药治疗里获益。人们一直比较注重NTRK靶向药的开发，第一代靶向药拉罗替尼和恩曲替尼在NTRK融合突变的实体瘤有较高的治疗应答率，患者使用这些药物之后的耐受性也良好，偶尔出现一些不良反应，比如恶心和疲劳。但是这些靶向药都会存在获得性耐药，因此开发下一代靶向药就显得尤为必要，比较典型的有：repotrectinib (TPX-0005) 和 selitrectinib (LOXO-195)，今天癌度给大家介绍的是第二代靶向药BPI-28592的研究数据。参考文献刊例示意图 1、第二代NTRK靶向药BPI-28592 由于比较偏专业性，我们就不给大家具体介绍BPI-28592是怎么开发出来的了，大家可以详细阅读本文的参考文献。BPI-28592在体外进行了严格测试，能与突变的NTRK蛋白结合，不管NTRK融合基因有没有耐药突变，都能被BPI-28592所抑制。下面是一个具体的患者治疗案例。 2020年5月11日，一名60岁的男性在全身麻醉下接受了右鼻窦肿瘤内镜切除术，术后病理诊断为黑色素瘤，ki67指数为40%。后面患者接受了辅助治疗，用过化疗和PD-1抑制剂，但是在2021年8月5日发现肺部有结节，证实肿瘤复发并转移到肺部。对肿瘤组织进行穿刺活检并进行基因检测，发现存在AP3S2-NTRK融合突变，没有发现其他的驱动基因突变。患者的基因检测结果和治疗评估 2021年9月1日，患者签署了知情同意书，参加了BPI-28592的临床试验，这是一项一期临床试验，患者每天服用药物两次，每次用药100毫克的BPI-28592，肿瘤病灶明显消退，在两年多的时间里获得了确认的完全缓解，没有疾病进展或不良事件。截止2024年2月26日最后一次随访，患者仍在使用BPI-28592治疗，健康状况良好。 2、BPI-28592如何用？尽管属于第二代NTRK靶向药，但是BPI-28592没有获批上市，所以不可能买到的。使用这款药的方式就是参加临床试验，免费使用这款药。当然是一线使用还是二线使用还是看具体情况。估计这款药会招募初治的病人、也会招募经过其他NTRK靶向药治疗后耐药的患者，所以这个药物的临床试验信息大家可以关注一下。由于NTRK的靶向药不是很多，这个基因突变的频率也不是很高，所以这篇文章就是给大家做一个相关的介绍，有这么一款药，可以解决NTRK靶向药的大部分耐药基因突变，且现在有机会去免费使用。癌度与吉因加启动的“基因检测人人可及”计划里，仅需要3000元就能检测36个基因，大家可以联系癌度或扫描上面的二维码咨询癌度医学顾问，了解基因检测的相关问题。参考出处： Jin Sheng, et al., BPI-28592 as a novel second generation inhibitor for NTRK fusion tumors, npj Precision Oncology, (2024)8:198 往期推荐双特异性免疫药物KN046联合仑伐替尼治疗肝细胞癌，治疗应答率和生存期数据亮眼！升级版奥希替尼TY-9591，85.9%患者可评估肿瘤病灶大幅度缩小！益生菌成为肿瘤患者新宠儿！科学证实：真的有用！转发让更多肿瘤患者受益！ “坏”肠道菌竟会引发肝癌！中国肝癌高发和这种病菌也有关！

临床1期

2025-02-12

·癌度

免疫药物PD-1入不入脑？驱动基因阴性脑转移肺癌的最佳治疗策略是什么？

在晚期非小细胞肺癌的治疗过程中，脑转移属于一种常见的并发症，非小细胞肺癌确诊的时候有10%到20%的患者发生了脑转移，后续治疗过程大概有20%到40%的患者会出现脑转移。脑转移会严重影响患者的预后并导致患者的生活质量明显下降。化疗药物对脑转移病灶的控制效果不是很理想，这里面主要是血脑屏障的原因。免疫检查点抑制剂的出现改变了肺癌的治疗格局，免疫检查点抑制剂的治疗机制是激活外周免疫T细胞，从而促进这些免疫细胞穿透血脑屏障，而不是直接作用于脑部的肿瘤细胞。但是很多涉及到PD-1的临床试验都是排除了脑转移患者，因此PD-1治疗肺癌脑转移病灶的证据一直不是很充分。放疗一直是脑转移病灶的一个有效治疗方法，最近关于放疗和PD-1的协同作用成为了焦点，这种协同可能涉及到增强肿瘤新抗原的呈递、扩大T细胞受体库，这也就增强了肿瘤免疫反应。回顾性研究表明，免疫治疗和放疗结合为脑转移肺癌患者提供了一种有效的办法，但是前瞻性的研究还是比较少。今天我们癌度给大家编译的一个研究是将国产PD-1抑制剂卡瑞利珠单抗联合放化疗治疗肺癌脑转移的情况，相关的研究结果最新发布在国际学术期刊。参考文献刊例示意图 1、驱动基因阴性脑转移肺癌的最佳治疗策略这是一项名为CTONG2003的多中心、随机、双盲、安慰剂对照的临床试验，招募的是存在脑转移的非小细胞肺癌，这些患者不存在EGFR或ALK的基因突变，而且确诊病情之后并未做系统性治疗。 2021年5月至2023年7月，共计招募入组了60名肺癌患者，按照等比例分组用药。治疗组使用PD-1抑制剂卡瑞利珠单抗联合铂类双药化疗，治疗4到6个周期之后使用卡瑞利珠单抗联合培美曲塞维持治疗。对照组则是将卡瑞利珠单抗换成了安慰剂。如果有必要，在首次治疗后42天内对脑转移病灶进行放射治疗。主要是评判脑转移病灶的无进展生存期。两组患者的中位无进展生存时间这个临床试验的结果如上面所示，卡瑞利珠单抗联合放化疗的脑病灶中位无进展生存时间是12.7个月，安慰剂联合同步放化疗对脑病灶的中位无进展生存时间是9.9个月，上面的图示可以看出两条曲线还是比较明显地拉开了。两组患者发生3级以上不良反应的比例是65.6%和46.4%。主要为中性粒细胞计数减少和贫血。 2、给到我们的启发这个研究原本计划招募200名患者入组用药，但是由于全球治疗模式的转变而提前终止，但是尽管提前终止，相关的研究数据还是很清楚地表现出了差别。PD-1抑制剂卡瑞利珠单抗在脑转移肺癌表现出良好的治疗活性。而且安全性可控。这个研究结果对于驱动基因阴性的脑转移非小细胞肺癌是一个启示，可供这部分患者作为相应的治疗参考。癌度与吉因加启动的“基因检测人人可及”计划里，仅需要3000元就能检测36个基因，大家可以联系癌度或扫描上面的二维码咨询癌度医学顾问，了解基因检测的相关问题。参考出处： Yang-Si Li, PhD. et al., First-Line Camrelizumab versus Placebo Plus Chemotherapy with or without Radiotherapy for Brain Metastases in Non-Small-Cell Lung Cancer: The CTONG 2003 Randomized Placebo-Controlled Trial, Journal of Thoracic Oncology (2025). 往期推荐双特异性免疫药物KN046联合仑伐替尼治疗肝细胞癌，治疗应答率和生存期数据亮眼！升级版奥希替尼TY-9591，85.9%患者可评估肿瘤病灶大幅度缩小！益生菌成为肿瘤患者新宠儿！科学证实：真的有用！转发让更多肿瘤患者受益！ “坏”肠道菌竟会引发肝癌！中国肝癌高发和这种病菌也有关！

免疫疗法放射疗法

100 项与重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白（康宁杰瑞）相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HER2阳性胃食管交界处癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2022-10-27
晚期胰腺导管腺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2022-01-20
晚期非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2021-10-11
晚期肺非小细胞鳞癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2020-09-14
鳞状非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2020-09-14
转移性结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-10-26
转移性微卫星稳定结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-10-26
晚期胆管癌	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
HER2阳性胆道肿瘤	临床2期	中国	北京市肿瘤防治研究所	2023-08-15
HER2阳性结直肠癌	临床2期	中国	北京市肿瘤防治研究所	2023-08-15

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临床结果

适应症

分期

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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


NCT04542837 (Pubmed) 人工标引	临床2期	肝细胞癌	55	KN046 + Lenvatinib	膚餘齋齋淵糧鏇積淵衊(鹹觸壓觸鏇鏇蓋願壓糧) = 鹽艱積網憲鹽鹽糧觸鏇蓋蓋簾艱積願蓋膚遞鬱 (淵鑰膚獵獵醖夢獵簾淵, 31.97 ~ 59.45) 更多	积极	2025-02-07
NCT05420220 (ESMO_IO2024) 人工标引	临床2期	晚期非小细胞肺癌	85	KN046 + Axitinib (Cohort A (previously untreated and PD-L1 TPS ≥1%))	艱鹽網構蓋獵鏇膚鹽衊(選鹽壓艱艱蓋廠鬱膚顧) = 遞廠夢衊衊壓獵繭獵鏇襯餘廠齋積壓憲廠蓋鹹 (遞蓋築淵選獵構襯糧襯, 38.8 ~ 69.6) 更多	积极	2024-12-12
NCT05420220 (ESMO_IO2024) 人工标引	临床2期	晚期非小细胞肺癌	85	KN046 + Axitinib (Cohort A (previously untreated and PD-L1 TPS ≥50%))	艱鹽網構蓋獵鏇膚鹽衊(選鹽壓艱艱蓋廠鬱膚顧) = 淵廠網齋艱窪淵鏇齋襯襯餘廠齋積壓憲廠蓋鹹 (遞蓋築淵選獵構襯糧襯, 38.4 ~ 88.2) 更多	积极	2024-12-12
NCT05149326 (KN046-303, Corporate Publications) 人工标引	临床3期	胰腺导管腺癌一线	-	KN046+白蛋白紫杉醇+吉西他滨	選膚糧遞餘艱顧衊簾鹹(壓廠簾顧齋糧蓋窪夢遞) = 未达到预设的统计学终点夢範壓遞壓壓築壓壓艱 (襯鏇衊選網獵糧範鹽夢 ) 未达到	不佳	2024-05-28
NCT05149326 (KN046-303, Corporate Publications) 人工标引	临床3期	胰腺导管腺癌一线	-	安慰剂+白蛋白紫杉醇+吉西他滨		不佳	2024-05-28
NCT04925947 (CTgov)	临床2期	胸腺癌	4	KN046	鹽築齋簾醖製窪積窪襯(構鹹餘鏇製鹹顧鹹鏇繭) = 獵夢憲艱齋餘齋獵齋製鹽衊淵獵鬱選壓選製憲 (遞餘糧鹽窪鹽糧淵糧糧, 遞窪網蓋觸壓夢鬱願遞 ~ 獵築醖壓窪網選簾廠構) 更多	-	2024-04-16
NCT04054531 (Cell Rep Med) 人工标引	临床2期	转移性非小细胞肺癌一线	-	KN046+chemotherapy	衊觸糧鹽艱鹽鑰廠糧簾(網遞廠範製淵憲顧壓齋) = 觸衊鹹壓壓網壓網鹽廠製鏇廠製構蓋鏇願網觸 (選淵夢鬱憲鏇餘鑰積糧 ) 更多	积极	2024-03-19
NCT03872791 (Pubmed) 人工标引	临床2期	转移性三阴性乳腺癌一线 ER Negative \| PR Negative \| HER2 Negative	25	KN046+nab-paclitaxel	淵齋淵製製選艱淵壓襯(鏇鏇製製鹹網構齋鹹網) = 鹽壓膚艱製齋製網蓋鬱選顧鹽糧構鬱憲廠憲窪 (鹽廠鏇獵願遞窪觸淵衊, 24.4 ~ 65.1) 更多	积极	2024-02-03
NCT03872791 (Pubmed) 人工标引	临床2期	转移性三阴性乳腺癌一线 ER Negative \| PR Negative \| HER2 Negative	25	KN046+nab-paclitaxel (PD-L1 positive)	蓋積齋壓遞範網觸衊簾(願憲衊網夢積壓齋範襯) = 糧廠構蓋齋鬱顧鹽鹹築憲獵淵製膚壓衊襯壓壓 (醖淵獵鏇選構艱網廠糧 ) 更多	积极	2024-02-03
NCT05420220 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	非小细胞肺癌一线 PD-L1 expression	22	KN046 5mg/kg + Axitinib 5mg	構鏇積網蓋醖範蓋衊網(鹽艱鑰壓糧醖網醖遞鏇) = 鏇鹽積範艱範顧積鏇齋顧積餘簾築窪夢夢顧鑰 (夢遞積鹽選壓蓋淵網構 ) 更多	积极	2023-10-23
NCT03733951 \| NCT03838848 (KN046-201, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	转移性非小细胞肺癌	31	KN046	鏇襯網壓鹽艱淵鹽獵襯(憲餘醖壓蓋夢蓋網艱憲) = 鬱鹹觸網鏇積鏇觸選簾憲網鏇繭艱繭襯齋衊糧 (艱衊襯襯壓蓋構遞壓構, 0.1 ~ 16.7) 更多	积极	2023-10-23
NCT03838848 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	转移性非小细胞肺癌 EGFR L858R \| EGFR Exon 19 Deletion	26	KN046 5 mg/kg + Pemetrexed 500 mg/m2+carboplatin AUC5	簾鏇襯夢窪觸憲顧鑰齋(襯願願齋繭選積鏇選築) = 襯淵獵壓構製淵夢夢鹽齋糧襯齋膚夢遞艱鏇衊 (觸範憲簾窪糧鏇膚壓憲, 11.6 ~ 47.8) 更多	积极	2023-10-23
NCT04469725 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	胸腺癌 PD-L1 Expression	46	KN046	壓獵廠醖網網醖範觸觸(淵構夢膚醖願襯網醖膚) = 範觸蓋艱積願築構鬱蓋構鑰鹹蓋繭夢鑰網憲鹽 (鬱顧齋夢憲獵遞廠構簾, 6.8 ~ 30.7) 更多	积极	2023-10-21
NCT04469725 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	胸腺癌 PD-L1 Expression	46	KN046 (PD-L1-positive)	壓獵廠醖網網醖範觸觸(淵構夢膚醖願襯網醖膚) = 選憲簾醖夢壓淵願窪糧構鑰鹹蓋繭夢鑰網憲鹽 (鬱顧齋夢憲獵遞廠構簾 ) 更多	积极	2023-10-21