A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC

开始日期2023-04-25

申办/合作机构

浙江劲方药业有限公司

CTIS2022-501451-87-00 / Not yet recruiting

A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation - GFH925X0201

开始日期2023-04-14

申办/合作机构-

NCT05699993 / Completed临床1期

An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects

This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.

开始日期2023-03-10

申办/合作机构

信达生物制药（苏州）有限公司

100 项与氟泽雷塞相关的临床结果

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100 项与氟泽雷塞相关的转化医学

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100 项与氟泽雷塞相关的专利（医药）

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项与氟泽雷塞相关的文献（医药）

2024-11-01·EUROPEAN JOURNAL OF CANCER

Potent covalent irreversible inhibitor of KRAS G12C IBI351 in patients with advanced solid tumors: First-in-human phase I study

Article

作者: Zhang, Zhiye ; Hu, Sheng ; Huang, Mengna ; Shan, Jinlu ; Zhu, Haibo ; Huang, Jingjing ; Zhou, Hui ; Zhang, Sujie ; Sun, Longhua ; Zhou, Qing ; Yang, Nong ; Li, Xingya ; Zhao, Jun ; Yu, Yan ; Sun, Meili ; Zhao, Mingfang ; Chu, Qian ; Huang, Dingzhi ; Zhang, Tongmei ; Cheng, Lingge ; Dong, Xiaorong ; Wang, Huijuan ; Liu, Lian ; Meng, Xiangjiao ; Yuan, Ying ; Wu, Dongde ; Wang, Xiang ; Wu, Yi-Long

BACKGROUND:

IBI351 is an irreversible and covalent inhibitor of KRAS G12C. Despite FDA approval of two KRAS G12C inhibitors, there are still significant unmet clinical needs in Chinese patients and ongoing concerns about the optimal dosage. Herein, we presented the phase Ia/Ib study of IBI351 monotherapy in Chinese patients with advanced solid tumors harboring KRAS G12C mutation.

METHODS:

In phase Ia dose escalation, IBI351 at 250/450/700/900 mg once daily and 450/600/750 mg twice daily (BID) were evaluated. Potentially efficacious doses and optimal recommended phase 2 dose (RP2D) were further evaluated in patients with advanced non-small cell lung cancer (NSCLC) in phase Ia dose expansion and phase Ib. Safety, pharmacokinetics, and investigator-assessed tumor response were evaluated.

RESULTS:

As of June 13, 2023, 176 patients were enrolled. IBI351 was well tolerated with no dose-limiting toxicity reported across all evaluated doses. The RP2D was determined as 600 mg BID by considering safety, efficacy and pharmacokinetics. A total of 168 patients (95.5 %) had at least one treatment-related adverse event (TRAE), and 64 patients (36.4 %) had grade 3 or higher TRAEs, most commonly gamma-glutamyl transferase increased (10.2 %) and anemia (6.8 %). For patients with NSCLC, the confirmed objective response rate (ORR) was 45.5 % across all doses. At 600 mg BID, the confirmed ORR was 46.8 % and median progression-free survival was 9.6 months with a median follow-up of 6.9 months.

CONCLUSIONS:

IBI351 was well tolerated in patients with advanced solid tumors and showed promising antitumor activity in advanced NSCLC patients with KRAS G12C mutation.

2024-08-01·Journal of Thoracic Oncology

Efficacy and Safety of KRAS G12C Inhibitor IBI351 Monotherapy in Patients With Advanced NSCLC: Results From a Phase 2 Pivotal Study

Article

作者: Fan, Yun ; Shan, Jinlu ; Huang, Mengna ; Pan, Yueyin ; Zhuang, Wu ; Huang, Jingjing ; Lin, Jiaxin ; Zhou, Hui ; Zhang, Sujie ; Sun, Meili ; Huang, Jianan ; Zhou, Qing ; Wang, Xiuwen ; Yu, Yan ; Yang, Nong ; Xu, Chongrui ; Sun, Longhua ; Sun, Jiya ; Guo, Renhua ; Zhao, Mingfang ; Meng, Xiangjiao ; Huang, Dingzhi ; Yuan, Ying ; Chu, Qian ; Liu, Lian ; Hu, Yi ; Wu, Yi-Long

INTRODUCTION:

KRAS glycine-to-cysteine substitution at codon 12 (G12C) mutation is a well-recognized and increasingly promising therapeutic target with huge unmet clinical needs in NSCLC patients. IBI351 is a potent covalent and irreversible inhibitor of KRAS G12C. Here, we present the efficacy and safety of IBI351 from an open-label, single-arm, phase 2 pivotal study.

METHODS:

Eligible patients with NSCLC with KRAS G12C who failed standard therapy were enrolled. IBI351 was orally administered at a dose of 600 mg twice daily. The primary endpoint was confirmed objective response rate assessed by an independent radiological review committee (IRRC) as per Response Evaluation Criteria in Solid Tumors v1.1. Other endpoints were safety, IRRC-confirmed disease control rate, duration of response, progression-free survival (PFS), and overall survival.

RESULTS:

As of December 13, 2023, 116 patients were enrolled (Eastern Cooperative Oncology Group Performance Status 1: 91.4%; brain metastasis: 30.2%; prior treatments with both anti-PD-1 or anti-PD-L1 inhibitors and platinum-based chemotherapy: 84.5%). As per the IRRC assessment, the confirmed objective response rate was 49.1% (95% confidence interval [CI]: 39.7-58.6), and the disease control rate was 90.5% (95% CI: 83.7-95.2). The median duration of response was not reached whereas disease progression or death events occurred in 22 patients (38.6%), and the median PFS was 9.7 months (95% CI: 5.6-11.0). overall survival data was immature. Treatment-related adverse events (TRAEs) occurred in 107 patients (92.2%) whereas 48 patients (41.4%) had equal to or higher than grade three TRAEs. Common TRAEs were anemia (44.8%), increased alanine aminotransferase (28.4%), increased aspartate aminotransferase (27.6%), asthenia (26.7%) and presence of protein in urine (25.0%). TRAEs leading to treatment discontinuation occurred in nine patients (7.8%). In biomarker evaluable patients (n = 95), all patients had positive KRAS G12C in tissue whereas 72 patients were blood-positive and 23 were blood-negative for KRAS G12C. Patients with KRAS G12C in both blood and tissue had higher tumor burden at baseline (p < 0.05) and worse PFS (p < 0.05). Tumor mutation profiling identified tumor protein p53 (45.3%), serine/threonine kinase 11 (STK11) (30.5%), and kelch-like ECH-associated protein 1 (21.1%) as the most common genes co-mutated with KRAS G12C. Among 13 genes with mutation frequency equal to or higher than 5%, mutations of six genes (STK11, kelch-like ECH-associated protein 1, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit gamma, DNA polymerase epsilon, SMAD family member 4, and BMP/retinoic acid-inducible neural-specific protein 3) were significantly associated with worse PFS (p < 0.05). Mutation in STK11 was also found to have a significant association with higher tumor burden at baseline and lower response rate (p < 0.05).

CONCLUSIONS:

IBI351 monotherapy demonstrated promising and sustained efficacy with manageable safety, supporting its potential as a new treatment option for KRAS G12C-mutant NSCLC.

2024-01-01·Journal of Biomedical Research

Study of the mass balance, biotransformation, and safety of [<sup>14</sup>C]IBI351 in healthy Chinese subjects

Article

作者: Zhou, Chen ; Shirui Zheng ; Zhu, Bei ; Tianqi Zhong ; Lin, Wen ; Cheng, Lingge ; Chen, Juan ; Peng Yan ; Shuaishuai Wang ; Yan, Peng ; Han, Feng ; Lulu Zhang ; Yipeng Cheng ; Zhang, Lulu ; Bilal Ahmed ; Zhao, Jun ; Jun Zhao ; Ahmed, Bilal ; Feng Han ; Lijun Xie ; Chen Zhang ; Lingge Cheng ; Zhang, Chen ; Wen Lin ; Chen Zhou ; Wang, Shuaishuai ; Xie, Lijun ; Bei Zhu ; Cheng, Yipeng ; Zhong, Tianqi ; Hao Feng ; Zheng, Shirui ; Juan Chen ; Feng, Hao

IBI351, a synthetic compound, exerts its anti-tumor effects by specifically, covalently, and irreversibly modifying the 12th cysteine residue of KRAS G12C. However, the pharmacokinetic characteristics of IBI351 in the human body have not been reported. The current study aimed to investigate the pharmacokinetics and safety of IBI351 in healthy Chinese male subjects. A single oral dose of 600 mg/150 μCi [ ¹⁴C]IBI351 was administered to six healthy male subjects. Blood, urine, and fecal samples were collected at continuous time points to analyze the levels of IBI351 parent drug and its metabolites. We found that IBI351 showed favorable pharmacokinetic characteristics, and was well tolerated in all the six participants. In addition, 17 major metabolites of IBI351 were analyzed and identified in the blood, urine, and feces. The main metabolic pathways included oxidation, hydrogenation, sulfonate conjugation, glucuronide conjugation, and cysteine conjugation. IBI351 and its metabolites were primarily excreted through feces. Taken together, this is the first study on the metabolism and safety of IBI351 in Chinese subjects, and these findings may guide future clinical development of IBI351 as a novel anti-tumor drug.

241

项与氟泽雷塞相关的新闻（医药）

2024-11-01

·药智网

信达生物还是“优等生”吗？

10月30日，信达生物公布2024年第三季度产品收入情况，共取得总产品收入超过人民币23亿元，同比增长40%。结合公司半年报，信达生物今年前9个月，产品总收入超过61亿元，较上年同比增长约51%。图1 2019-2024年信达生物产品收入情况数据来源：信达生物财报业绩增长主要来源于： PD-1单抗达伯舒（信迪利单抗注射液）广阔的适应症与国家医保目录覆盖及准入渠道优势带来的业绩持续增长；商业化产品组合扩充至11款，新产品带来新的销售业绩。在研产品方面，信达生物目前还有5个品种在国家药品监督管理局审评中，3个新药分子进入3期或关键性临床研究，另外约17个新药品种已进入临床研究。仅今年，信达生物就有6个1类新药首次在国内获批临床。 01 200亿目标再进一步 2022年，信达生物喊出“2027年国内产品收入达到200亿元”的目标。信达2024年Q3产品收入23亿元，同比增长40%，如果在未来三年，信达能保持这一增速，2027年其产品收入将达到甚至超出200亿这一目标。图片来源：信达生物信达生物将其产品线聚焦于癌症、免疫、心血管及代谢、眼科这四大领域。目前信达生物已有11个商业化产品，其中9个为抗肿瘤药（信迪利单抗、氟泽雷塞、伊基奥仑赛、贝伐珠单抗、利妥昔单抗、佩米替尼、奥雷巴替尼、雷莫西尤单抗、塞普替尼）；代谢类1个（托莱西单抗）；自免类1个（阿达木单抗）；眼科领域还没有新药上市，但IBI-311（替妥尤单抗）已提交上市申请。另外，信达还有5个品种在国家药品监督管理局审评中，包括备受关注的GLP-1R/GCGR双靶激动剂玛仕度肽、甲状腺眼病新药IBI311、银屑病新药匹康奇拜单抗等。肿瘤肿瘤是信达生物最看重的领域。其信迪利单抗（达伯舒，Tyvyt）是第二个上市的国产PD-1单抗，目前适应症已覆盖五大高发瘤种一线治疗，且已全部纳入国家医保目录。虽已上市多年，但信迪利单抗销售额依然保持高速增长，今年前三季度销售额约28亿元，占信达总产品收入的近一半。图片来源：雪球今年，信达生物又斩获了首个国产KRAS G12C抑制剂——氟泽雷塞片（达伯特），用于至少接受过一种系统性治疗的KRAS G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者。 KRAS作为常见的致癌驱动突变，曾有‘不可成药’靶点之称。氟泽雷塞片是中国首个获批的KRAS G12C抑制剂，原研为劲方医药，信达于2021年9月引进该药在中国的开发和商业化权利。该药的获批为信达的肿瘤管线增添了一员强将。在自研方面，信达继续发挥其抗体平台的优势，拓展“IO+ADC”，已布局10+个ADC、双抗、多抗、双抗ADC，潜力管线众多，包括IBI363(PD-1/IL-2双抗)、IBI343(CLDN18.2 ADC)、BI389(CLDN18.2/CD3双抗)、IBI133(HER3 ADC)、IBI3003(GPRC5D/BCMA/CD3)等。 IBI363：是一款“全球新”的PD-1/IL-2双特异性融合蛋白，可能也是信达最具有国际化前景的新药。根据信达新闻稿，IBI363不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在PD-1耐药和转移模型中也表现出了突出的抑瘤效力。今年9月，该药获得美国FDA授予快速通道资格，拟定适应症为既往接受过至少一线含PD-1/L1检查点抑制剂系统性治疗后进展的局部晚期或转移性黑色素瘤。 IBI343：是一款潜在同类最佳CLDN18.2 ADC，在胰腺癌、胃癌治疗上展现出积极信号。BI343单药用于二线胰腺癌治疗已获得美国FDA的快速通道药物认定。 IBI389：是一款新型CLDN18.2/CD3双特异性抗体。在1期临床研究中，IBI389在GC及PDAC上展现出初步疗效。另外，信达还在推进更多抗肿瘤管线至临床阶段，仅今年，信达生物就有6个1类新药首次在国内获批临床，包括多个ADC、多特异性抗体。心血管和代谢（CVM）信达生物在CVM领域已有一款PCSK9靶向降脂单抗托莱西单抗获批，用于治疗原发性高胆固醇血症和混合型血脂异常。该药也于近日参加了2024年医保谈判，有望进入新一版医保目录，实现放量销售。另外，信达从礼来引进的GLP-1R/GCGR双靶激动剂——玛仕度肽，在糖尿病和减重领域都展现了非凡潜力，有望成为信达下一个重磅产品。目前，该药用于成人2型糖尿病和体重管理两项适应症均已提交上市申请。图片来源：信达生物此外，信达生物CVM领域的管线还有新一代痛风高尿酸血症候选分子IBI128(XOl)和高血压小核酸疗法IBI3016(AGT)。自身免疫信达生物的匹康奇拜单抗(IBI112)是一款IL-23p19单抗，具有同类最佳疗效潜力和长间隔给药，目前已提交NDA，适应症为中重度斑块状银屑病。另外，匹康奇拜单抗还在开展在中重度活动性溃疡性结肠炎患者中II期临床研究，未来有望成为自免领域的一款重磅药物。信达其他自免管线还有：IBI353(PDE4)、IBI355(CD40L)、IBI356(OX40L)，以及全球首创双抗分子IBI3002(IL-4Rα/TSLP)等。眼科疾病 IBI311（替妥尤单抗）是一款重组抗胰岛素样生长因子1受主（IGF-1R）单克隆抗体。其首个甲状腺眼病新药临床Ⅲ期RESOTRE-1于2024年2月达到主要研究终点，治疗甲状腺眼病（TED）突眼改善显著、安全性良好，目前已递交NDA。图片来源：信达生物另外，信达的眼用抗VEGF/补体的双特异性融合蛋白IBI302，展现出非劣于阿柏西普的视力获益、更长给药间隔下的疗效持久性和黄斑萎缩改善的潜力。目前IBI302 8mg治疗nAMD的3期临床试验STAR患者招募入组进行中。 02 出海风波再起出海，是国内创新药企的另一个重要话题。无论是百济神州、传奇生物的创新药在海外的销售额屡创新高，还是百利天恒、同润医药等将管线license out的巨额首付款，都证明了出海才是打破国内创新药天花板的必走之路。但是，信达生物的海外进展似乎略显缓慢，但又一直被寄予厚望。近日信达生物创始人俞德超斥资2050万美元（约1.46亿元），增持信达海外业务子公司Fortvita 20%股权的消息再度引发市场对其海外业务的关注。图片来源：信达生物根据公告，信达生物全资附属公司Fortvita与Lostrancos签订了认购协议，Lostrancos认购Fortvita部分股权，认购价为2050万美元。交割完成后，信达生物持有的Fortvita股份被摊薄至79.61%，Lostrancos直接持有20.39%。而信达生物的创始人、董事长兼CEO俞德超是Lostrancos的唯一董事，直接持有82.93%的股权，信达生物执行董事、前首席财务官奚浩与另一名投资者（独立第三方）共同持有17.07%的股权。根据公开资料，Fortvita于2018年成立，专为信达创新药出海而设立。信达表示目前已与Fortvita的资产划分已完成，出于保密要求不公开具体管线。不过，据专利等公开资料，Fortvita拥有PD-1/IL-2双抗、Claudin18.2 ADC、B7H3 ADC等潜力管线的海外权益。目前，Fortvita尚未盈利，对于信达高管增持Fortvita股份，增强出海的信心和决心无可置疑。但是，对于Fortvita以8000万美元净资产、1PB的估值，市场存在质疑声。虽然管理层一再强调Fortvita的管线绝大多数在海外都还处于临床前，个别在临床早期，但参考近几年国内创新管线license-out首付款动辄数亿美元，Fortvita这8000万美元的估值并不被广泛接受。无论如何，希望装载了信达生物出海前景的Fortvita能早日传来好消息。 03 结语信达生物作为中国最早一批Biotech，从PD-1开始商业化，目前其创新药单季收入已达23亿元，在研管线几乎囊括了所有热门领域，包括GLP-1R/GCGR双靶点激动剂玛仕度肽、甲状腺眼病新药IBI311(IGF-1R)、PD-1/IL-2双抗、Claudin18.2 ADC、CLDN18.2/CD3双抗等，无疑是国内创新药企的“优等生”。但是在国际化方面，信达生物还需要一个“重磅炸弹”来证明自己。声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

财报抗体药物偶联物临床3期申请上市医药出海

2024-10-31

·Pharma CMC

信达生物：三季度产品收入超23亿元，同比增长超40%

10月30日，信达生物发布2024年第三季度产品收入的最新消息，2024年第三季度，共取得总产品收入超过人民币23亿元，同比取得逾40%的显著增长。本季度内： 1）达伯舒®（信迪利单抗注射液）保持强劲增长势头，市场领先地位日益稳固，其他主要产品销售亦保持快速增长。这主要得益于产品广阔的适应症与国家医保目录覆盖及准入渠道优势； 2）信达生物已获批产品组合扩充至11款，新添一款肿瘤创新靶向药物达伯特®（氟泽雷塞片，KRASG12C抑制剂）获批上市，公司于肺癌突变治疗领域管线组合愈发完备、团队愈发成熟； 3）得益于有竞争力的产品和有效的市场策略，信达生物新产品市场渗透加速，为收入增长贡献新驱动力。截至目前，信达生物已取得11款产品获批上市，5个品种在国家药品监督管理局审评中，3个新药分子进入3期或关键性临床研究，另外约17个新药品种已进入临床研究。

临床3期上市批准

2024-10-30

·Insight数据库

信达三季报：营收超 23 亿元，同比大增 40%

10 月 30 日，信达公布 2024 年第三季度报告，本季度共取得总产品收入超过 23 亿元人民币，同比显著增长 40% 。本季度内： 1）达伯舒®（信迪利单抗注射液）保持强劲增长势头，市场领先地位日益稳固，其他主要产品销售亦保持快速增长。这主要得益于公司产品广阔的适应症与国家医保目录覆盖及准入渠道优势； 2）信达已获批产品组合扩充至 11 款，新添一款肿瘤创新靶向药物达伯特®（氟泽雷塞片，KRASG12C 抑制剂）获批上市，公司在肺癌突变治疗领域管线组合愈发完备、团队愈发成熟； 3）得益于有竞争力的产品和有效的市场策略，公司新产品市场渗透加速，为收入增长贡献新驱动力。截至目前，信达已有 11 款产品获批上市，5 个品种在上市审评中，3 个新药分子进入 3 期或关键性临床研究，另外约 17 个新药品种已进入临床研究。 11 款产品获批上市的产品数据来源：Insight 数据库 5 个品种在上市审评中的产品数据来源：Insight 数据库 Insight 数据库国内「申报进度」模块显示，2024 年以来（截至 10 月 28日），信达生物已有六款 1 类新药首次在国内获批临床：从药物类型来看，这些产品包括双抗、三抗、ADC，其中 ADC 最多，有 4 款。从治疗领域来看，适应症均为肿瘤，包括实体瘤和血液癌症。从临床试验地区来看，信达对这些新药都采取了澳大利亚和中国同步开展研究的策略。详细阅读：信达生物 6 款抗肿瘤 1 类新药首次获批临床，4 款为 ADC 封面来源：企业 logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

抗体药物偶联物临床3期上市批准申请上市财报

100 项与氟泽雷塞相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
KRAS G12C突变非小细胞肺癌	中国	信达生物制药（苏州）有限公司	2024-08-20

未上市

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适应症	最高研发状态	国家/地区	公司	日期
KRAS G12C突变结直肠癌	临床3期	美国	劲方医药科技（上海）股份有限公司初创企业	-
KRAS G12C突变的实体瘤	临床2期	中国	信达生物制药（苏州）有限公司	2021-09-10
非小细胞肺癌	临床1期	中国	浙江劲方药业有限公司	2023-02-13
KRAS G12C突变非鳞状非小细胞肺癌	临床1期	中国	信达生物制药（苏州）有限公司	2022-09-09

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临床结果

适应症

分期

评价

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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


NCT05504278 (WCLC2024) 人工标引	临床1期	非小细胞肺癌	116	IBI351 600 mg	築醖鹹獵鑰齋獵鹹艱鹽(鏇衊壓製廠製製鑰蓋範) = 鬱製襯壓獵願遞顧鏇鹹膚範襯獵構構鏇繭鏇鬱 (醖糧鏇遞鬱窪壓願夢鑰, 39.7 ~ 58.6) 更多	积极	2024-09-09
NCT05756153 (KROCUS, ASCO2024) 人工标引	临床2期	KRAS G12C突变非小细胞肺癌 KRAS G12C mutated	27	Fulzerasib+ Cetuximab	蓋廠觸獵窪選構糧顧廠(窪選繭遞蓋齋鏇餘鑰鬱) = 遞顧製膚夢淵鹹顧網鏇顧顧艱築夢壓艱衊築鏇 (蓋齋觸鹹構構糧糧願淵, 56.3) 更多	积极	2024-06-02
NCT05005234 (NEWS) 人工标引	临床1期	KRAS G12C突变非小细胞肺癌二线 KRAS G12C	67	IBI351	膚範夢簾鏇醖積積築積(獵觸構構築鏇廠願襯鑰) = 衊鏇選窪夢範鑰選糧齋積淵艱餘醖鏇鬱顧範襯 (網獵夢選窪願膚壓願醖 ) 更多	积极	2023-12-04
NCT05005234 (NEWS) 人工标引	临床1期	KRAS G12C突变非小细胞肺癌二线 KRAS G12C	67	IBI351 (600 mg 每天两次)	膚範夢簾鏇醖積積築積(獵觸構構築鏇廠願襯鑰) = 糧壓網選觸醖醖鬱鹽壓積淵艱餘醖鏇鬱顧範襯 (網獵夢選窪願膚壓願醖 ) 更多	积极	2023-12-04
NCT05005234 (NEWS) 人工标引	临床1期	KRAS G12C突变非小细胞肺癌二线 KRAS G12C	55	IBI351	蓋鑰鏇網糧簾糧憲鑰觸(鑰艱鏇獵膚艱積廠積夢) = 範網積範選餘範積網鹹積獵憲糧壓壓簾遞繭積 (蓋膚餘繭膚窪積範鹹膚 ) 更多	积极	2023-12-04
NCT05005234 (NEWS) 人工标引	临床1期	KRAS G12C突变非小细胞肺癌二线 KRAS G12C	55	IBI351 (RP2D)	蓋鑰鏇網糧簾糧憲鑰觸(鑰艱鏇獵膚艱積廠積夢) = 醖獵夢鑰觸製衊鏇憲築積獵憲糧壓壓簾遞繭積 (蓋膚餘繭膚窪積範鹹膚 ) 更多	积极	2023-12-04
NCT05005234 \| NCT05497336 (ESMO_ASIA2023) 人工标引	临床1期	KRAS G12C突变结直肠癌 KRAS G12C	56	IBI351 (600mg BID)	壓襯積獵鬱憲衊繭觸壓(鏇齋鑰鏇憲築顧鏇築壓) = 壓範積鑰衊鏇餘艱顧鹽願夢選選鬱遞範遞築窪 (憲製廠壓製積膚糧淵窪, 31.4 ~ 60.8) 更多	积极	2023-12-02
NCT05005234 (ESMO_ASIA2023) 人工标引	临床2期	KRAS G12C突变非小细胞肺癌 KRAS G12C	116	IBI351 600 mg	夢觸餘壓簾壓範遞鹽齋(壓願鏇壓積繭繭顧獵鏇) = 夢鑰艱鏇簾網網襯齋醖鹹憲繭窪夢醖艱製範壓 (鏇齋鹽夢製蓋顧醖範製, 37.2 ~ 56.0) 更多	积极	2023-12-01
NEWS 人工标引	临床1期	KRAS突变非小细胞肺癌二线 KRAS G12C	67	IBI351	壓蓋構糧鑰鑰遞艱築艱(觸餘糧廠簾壓選簾簾鑰) = 遞餘齋製夢醖餘窪簾壓鑰壓鹽鹽獵網築齋簾襯 (憲齋願構積廠網築積衊 ) 更多	积极	2023-11-24
NEWS 人工标引	临床1期	KRAS突变非小细胞肺癌二线 KRAS G12C	67	IBI351 (600mg BID)	觸膚廠顧選齋觸積遞壓(鑰窪網顧夢顧鏇鏇衊築) = 構蓋鏇範醖糧鏇築願鬱網壓糧衊積窪遞襯蓋廠 (構獵構艱選積製築顧衊, 39.8 ~ 91.7) 更多	积极	2023-11-24
NCT05005234 \| NCT05497336 (ASCO2023) 人工标引	临床1期	实体瘤 KRASG12C mutation	32	IBI351 600mg BID	艱襯積鑰淵鹽糧範膚鬱(膚選構製衊網餘鏇窪餘) = 顧鹽艱膚獵壓淵觸鏇網餘築膚醖襯糧壓憲淵範 (艱窪構齋鹹選遞鹹憲艱 ) 更多	积极	2023-05-31
NCT05005234 (AACR2023) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	74	IBI351	醖膚鹽餘製壓廠鏇築廠(夢夢積蓋衊選鑰顧憲窪) = 遞醖齋鑰壓廠醖憲壓鹽鏇製鑰鬱遞繭網夢窪壓 (網繭鏇鏇夢憲糧鬱蓋遞 )	积极	2023-04-14
NCT05005234 (AACR2023) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	74	IBI351 (response-evaluable NSCLC pts)	膚顧鏇糧鹽構齋鬱網廠(鏇衊壓簾憲範製壓艱膚) = 築製餘鹽艱襯選範艱構艱窪願簾鏇醖獵蓋鑰獵 (積顧廠築範獵膚選網餘, 83.4 ~ 97.5) 更多	积极	2023-04-14
NCT05005234 (ASCO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤 KRAS G12C	15	IBI351	鏇遞築鹹願夢壓衊顧壓(醖鏇繭淵鬱淵願襯積網) = 築襯積糧構顧構壓顧構網鏇範構齋構憲積鹽齋 (餘襯製遞餘醖糧觸遞顧 ) 更多	积极	2022-06-02