更新于：2024-05-01

Ganitumab

盖尼塔单抗

更新于：2024-05-01

概要

概要

基本信息

药物类型

单克隆抗体

别名

Ganitumab (USAN/INN)

靶点

IGF-1R

作用机制

IGF-1R拮抗剂(胰岛素样生长因子-I受体拮抗剂)

治疗领域

肿瘤呼吸系统疾病皮肤和肌肉骨骼疾病+ [1]

在研适应症

骨转移癌尤文肉瘤外周性原始神经外胚层肿瘤+ [3]

非在研适应症

晚期癌症晚期恶性实体瘤晚期胰腺神经内分泌肿瘤+ [19]

原研机构

Amgen, Inc.

在研机构

National Cancer Institute

Dana-Farber Cancer Institute, Inc.

非在研机构

Amgen, Inc.

Translational Research In Oncology

ImmunityBio

+ [2]

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

序列信息

Sequence Code 13007076H

来源: *****

Sequence Code 193853L

来源: *****

关联

项与盖尼塔单抗相关的临床试验

NCT04199026 / Not yet recruiting早期临床1期IIT

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Sarcomas

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

开始日期2025-01-31

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT04129151 / Completed临床2期IIT

Phase 2 Trial of Palbociclib and Ganitumab in Patients With Relapsed or Refractory Ewing Sarcoma

This research study is designed to study the combination of two drugs, palbociclib and ganitumab, as a potential treatment for Ewing sarcoma.
The names of the study drugs involved in this study are:
Palbociclib
Ganitumab

开始日期2019-12-05

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+2]

NCT03041701 / Terminated临床1/2期IIT

A Phase I/II Trial of the Insulin-Like Growth Factor 1 Receptor (IGF-1R) Antibody AMG479 (Ganitumab) in Combination With the Src Family Kinase (SFK) Inhibitor Dasatinib in Patients With Embryonal and Alveolar Rhabdomyosarcoma

Background:
Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood. Two types are embryonal RMS (ERMS) and alveolar RMS (ARMS). Dasatinib may block over-expression of a certain enzyme. Ganitumab may block a certain growth factor, which might suppress tumor growth. This drug combination may help slow tumor growth in people with ERMS and ARMS.
Objective:
To see if dasatinib combined with ganitumab is safe and shrinks or slows the growth of tumors in people with ERMS and ARMS.
Eligibility:
People any age who have ERMS or ARMS that did not respond to previous treatment and who can swallow tablets
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Scans/x-rays
Tissue sample: This can be from previous surgery or biopsy.
Optional biopsy: A small piece of the tumor is removed with a needle.
Participants will be asked to co-enroll in another protocol.
Participants will get a drug interaction handout and wallet card that show what foods and medications to avoid.
Participants will be treated in cycles. The first cycle is 35 days, and the rest are 28 days. Participants will take dasatinib by mouth daily. They will get ganitumab through an intravenous (IV) every 2 weeks. They will have a physical exam every 1-2 weeks, and urine and heart tests before most cycles.
Participants will continue treatment as long as they do not have severe side effects, or their tumors do not get worse.
After ending treatment, participants will have a visit. This includes repeats of the screening tests.

开始日期2017-07-07

申办/合作机构

National Cancer Institute

100 项与盖尼塔单抗相关的临床结果

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100 项与盖尼塔单抗相关的转化医学

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100 项与盖尼塔单抗相关的专利（医药）

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项与盖尼塔单抗相关的文献（医药）

2023-07-03·Clinical cancer research : an official journal of the American Association for Cancer Research

Phase I trial of ganitumab plus dasatinib to cotarget the insulin-like growth factor 1 receptor and Src family kinase YES in rhabdomyosarcoma.

Article

作者: Srivandana Akshintala ; R Taylor Sundby ; Donna Bernstein ; John W Glod ; Rosandra N Kaplan ; Marielle E Yohe ; Andrea M Gross ; Joanne Derdak ; Haiyan Lei ; Alexander Pan ; Eva Dombi ; Isabel Palacio-Yance ; Kailey R Herrera ; Markku M Miettinen ; Helen X Chen ; Seth M Steinberg ; Lee J Helman ; Leo Mascarenhas ; Brigitte C Widemann ; Fariba Navid ; Jack F Shern ; Christine M Heske

PURPOSE:

Antibodies against IGF-1R have shown meaningful but transient tumor responses in patients with rhabdomyosarcoma (RMS). The SRC family member YES has been shown to mediate IGF-1R antibody acquired resistance, and cotargeting IGF-1R and YES resulted in sustained responses in murine RMS models. We conducted a phase I trial of the anti-IGF-1R antibody ganitumab combined with dasatinib, a multi-kinase inhibitor targeting YES, in RMS patients (NCT03041701).

PATIENTS AND METHODS:

Patients with relapsed/refractory alveolar or embryonal RMS and measurable disease were eligible. All patients received ganitumab 18 mg/kg intravenously every 2 weeks. Dasatinib dose was 60 mg/m2/dose (max 100 mg) oral once daily [dose level (DL)1] or 60 mg/m2/dose (max 70 mg) twice daily (DL2). A 3+3 dose escalation design was used, and maximum tolerated dose (MTD) was determined based on cycle 1 dose-limiting toxicities (DLTs).

RESULTS:

Thirteen eligible patients, median age 18 years (range 8-29) enrolled. Median number of prior systemic therapies was 3; all had received prior radiation. Of 11 toxicity-evaluable patients, 1/6 had a DLT at DL1 (diarrhea) and 2/5 had a DLT at DL2 (pneumonitis, hematuria) confirming DL1 as MTD. Of nine response-evaluable patients, one had a confirmed partial response (PR) for four cycles, and one had stable disease (SD) for six cycles. Genomic studies from cell-free DNA correlated with disease response.

CONCLUSIONS:

The combination of dasatinib 60 mg/m2/dose daily and ganitumab 18 mg/kg every two weeks was safe and tolerable. This combination had a disease control rate of 22% at five months.

2023-06-12·Cancer medicine

Phase 2 trial of palbociclib and ganitumab in patients with relapsed Ewing sarcoma.

Article

作者: David S Shulman ; Priscilla Merriam ; Edwin Choy ; Lillian M Guenther ; Kerri L Cavanaugh ; Pei-Chi Kao ; Andrew Posner ; Ketki Bhushan ; Grace Fairchild ; Emma Barker ; Kelly Klega ; Kimberly Stegmaier ; Brian D Crompton ; Wendy B London ; Steven G DuBois

BACKGROUND:

Ewing sarcoma (EWS) is an aggressive sarcoma with few treatment options for patients with relapsed disease. Cyclin-dependent kinase 4 (CDK4) is a genomic vulnerability in EWS that is synergistic with IGF-1R inhibition in preclinical studies. We present the results of a phase 2 study combining palbociclib (CDK4/6 inhibitor) with ganitumab (IGF-1R monoclonal antibody) for patients with relapsed EWS.

PATIENTS AND METHODS:

This open-label, non-randomized, phase 2 trial enrolled patients ≥12 years with relapsed EWS. All patients had molecular confirmation of EWS and RECIST measurable disease. Patients initially received palbociclib 125 mg orally on Days 1-21 and ganitumab 18 mg/kg intravenously on Days 1 and 15 of a 28-day cycle. The primary endpoints were objective response (complete or partial) per RECIST and toxicity by CTCAE. An exact one-stage design required ≥4 responders out of 15 to evaluate an alternative hypothesis of 40% response rate against a null of 10%. The study was closed following enrollment of the 10th patient due to discontinuation of ganitumab supply.

RESULTS:

Ten evaluable patients enrolled [median age 25.7 years (range 12.3-40.1)]. The median duration of therapy was 2.5 months (range 0.9-10.8). There were no complete or partial responders. Three of 10 patients had stable disease for >4 cycles and 2 had stable disease at completion of planned therapy or study closure. Six-month progression-free survival was 30% (95% CI 1.6%-58.4%). Two patients had cycle 1 hematologic dose-limiting toxicities (DLTs) triggering palbociclib dose reduction to 100 mg daily for 21 days. Two subsequent patients had cycle 1 hematologic DLTs at the reduced dose. Eighty percent of patients had grade 3/4 AEs, including neutropenia (n = 8), white blood cell decreased (n = 7), and thrombocytopenia (n = 5). Serum total IGF-1 significantly increased (p = 0.013) and ctDNA decreased during the first cycle.

CONCLUSIONS:

This combination lacks adequate therapeutic activity for further study, though a subset of patients had prolonged stable disease.

2023-01-27·Gynecologic oncology

Results of TRIO-15, a multicenter, open-label, phase II study of the efficacy and safety of ganitumab in patients with recurrent platinum-sensitive ovarian cancer.

Article

作者: T M Davidson ; C L Lebreton ; A E Wahner Hendricksen ; H J Atkinson ; M C Larson ; A L Oberg ; D M Provencher ; J A Glaspy ; B Y Karlan ; D J Slamon ; G E Konecny ; I L Ray-Coquard

BACKGROUND:

IGF signaling has been implicated in the pathogenesis and progression of ovarian carcinoma (OC). Single agent activity and safety of ganitumab (AMG 479), a fully human monoclonal antibody against IGF1R that blocks binding of IGF1 and IGF2, were evaluated in patients with platinum-sensitive recurrent OC.

METHODS:

Patients with CA125 progression (GCIG criteria) or measurable disease per RECIST following primary platinum-based therapy received 18 mg/kg of ganitumab q3w. The primary endpoint was objective response rate (ORR) assessed per RECIST 1.1 by an independent radiology review committee (IRC) and/or GCIG CA125 criteria. Secondary endpoints included clinical benefit rate (CBR), progression free survival (PFS) and overall survival (OS).

RESULTS:

61 pts. were accrued. Objective responses were seen in 5/61 patients (ORR 8.2%, 95% CI, 3.1-18.8) with 1 partial response (PR) by RECIST and 2 complete responses (CR) as well as 2 PR by CA125 criteria. CBR was 80.3% (95% CI, 67.8-89.0%). The median PFS according to RECIST by IRC was 2.1 months (95% CI, 2.0-3.1). The median PFS per RECIST IRC and/or CA125 was 2.0 months (95% CI, 1.8-2.2). The median OS was 21 months (95% CI, 19.5-NA). The most common overall adverse events were fatigue (36.1%) and hypertension (34.4%). Grade 1/2 hyperglycemia occurred in 30.4% of patients. Hypertension (11.5%) and hypersensitivity (8.2%) were the most frequent grade 3 adverse events.

CONCLUSIONS:

IGF1R inhibition with ganitumab was well-tolerated, however, our results do not support further study of ganitumab as a single agent in unselected OC patients.

项与盖尼塔单抗相关的新闻（医药）

2023-12-14

·Business Wire

Insulin-Like Growth Factor Immunotherapy Advances: Crucial Findings on IGF-1R-Inhibiting Therapies Unveiled in Latest Research Publication - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "IGF-1R- and IGF-1 Targeted Immunotherapy Pipeline Review" report has been added to ResearchAndMarkets.com's offering. This research explores the current landscape of immunotherapy treatments targeting the insulin-like growth factor-1 receptor (IGF-1R), a significant player in oncological advancements. The detailed study delves into the intricate relationships between IGF-1R and various cancer types, offering valuable insights into the prospects and challenges of IGF-1R inhibitors and associated therapeutic approaches. IGF-1R Immunotherapy's Role Beyond Oncology The research publication also captures the significance of IGF-1R inhibition in conditions beyond cancer, particularly noting its overexpression in immune cells related to thyroid ophthalmopathy in Graves' disease. Understanding the role of IGF-1R can lead to enhanced therapeutic interventions aimed at mitigating inflammatory processes and improving symptoms in affected patients. This robust body of work encapsulates the critical developments in IGF-1R-targeted immunotherapy, offering a treasure trove of information to stakeholders in the biopharmaceutical industry, research institutions, healthcare professionals, and policy-makers. Expanding IGF-1R Inhibition Therapeutics: A Glimpse into the Future The document underscores the complexities and potential of targeting IGF-1 receptor pathways, thrusting readers to the forefront of immunotherapeutic innovation. The nuanced findings in our report are crucial for guiding future research directions, optimizing treatment regimens, and ultimately enhancing patient care within the realm of precision medicine. The discoveries and analyses presented in this publication not only illuminate the path for future scientific inquiries but also underpin the strategic decisions that will shape the next generation of IGF-1R-targeted therapies. The implications of the findings extend to translational research, clinical application, and the broader biotech industry's approach to disease treatment and patient well-being. For those committed to staying abreast of the latest breakthroughs in targeted immunotherapy, exploring the wealth of information housed within the pages of this research document is indispensable. Key Highlights and Innovations in IGF-1R Immunotherapy The document presents critical developments through a tabulated competitors' overview, covering essential details such as drug codes, targets or mechanisms of action, compound classes, territorial reach of key competitors, indications, and the current stages of research and development. An in-depth project history section, providing links to relevant sources of information, including press releases, company homepages, academic abstracts, presentations, and annual reports, further enriches the report's content. Insightful analysis of past and ongoing clinical trials, including the performance of monoclonal antibodies such as figitumumab, ganitumab, and dalotuzumab in various phases of testing, with special emphasis on phase III clinical outcomes. Exploration of cutting-edge strategies that leverage IGF-1R's cell-signaling dynamics for targeted drug delivery, such as the use of antibody-drug conjugates and radioimmunoconjugates. For more information about this report visit https://www.researchandmarkets.com/r/litbge About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

免疫疗法AACR会议ASCO会议

2023-08-15

·PipelineReview

IGF-1R- and IGF-1 Targeted Immunotherapy Pipeline Review

BARCELONA, Spain I August 15, 2023 I La Merie Publishing released its newest product reviewing the pipeline of IGF-1R or IGF-1 targeted drugs or immunotherapy candidates: IGF-1R- and IGF-1 Targeted Immunotherapy Pipeline Review Target: Insulin-like growth factor-1 (IGF-1) & Receptor (IGF-1R Product Category: Antibody; Fusion Protein This product provides basic information on approved drugs and immunotherapy candidates in research and development targeting insulin-like growth factor-1 (IGF-1) or its receptor (IGF-1R). This product consists of: This product is delivered on the very same day of purchase by e-mail containing competitor and project history reports in pdf format and database credentials. Reports are prepared on the same day. IGF-1R is a key member of the insulin-like growth factor (IGF) axis, which involves in cancer development, metastasis and cancer therapeutic resistance. Anti-IGF-1R monoclonal antibody is among the first major therapeutic agents for IGF-1R inhibition. These antibodies inhibit the binding between IGF-1R and its ligands, thereby blocking the activation of IGF-1R homodimer and IGF-1R/InsR hybrid, but not the InsR homodimer. A number of fully human monoclonal antibodies, which target the α subunit of IGF-1R, have demonstrated anti-tumor activities in pre-clinical studies. After completion of early phase clinical trials, three of the IGF-1R antibodies (figitumumab, ganitumab, and dalotuzumab) were tested in phase III clinical trials. Another strategy is inhibiting the binding of IGF ligands to the receptor which can inactivate IGF-1R. Due to the lack of a clear clinical benefit in these phase III trials, further clinical research was not pursued. Meanwhile, several firms are taking advantage of elevated IGF-1 signaling in cancers to deliver therapeutic payloads directly to tumor tissue, e.g. by antibody-drug conjugates or radioimmunoconjugates. These drug programs exploit the fact that IGF-1R, upon binding to its ligand or an antibody, undergoes receptor-mediated endocytosis, resulting in internalization of any bound molecules. Off-target toxicity is minimized because IGF-1R activity is mostly limited to internal compartments of the cell in vital organs such as the heart, and only a few tissues in the bladder, prostate and endometrium show low to moderate surface expression of IGF-1R. IGF-1R is a transmembrane tyrosine kinase receptor that plays a role in development, metabolism, and immune regulation, and is overexpressed in orbital fibroblasts (OFs), B, and T cells of thyroid ophthalmopathy in Graves' disease. Blocking IGF-1(R) signalling reduces the expression of downstream inflammatory factors, thereby inhibiting the synthesis of hyaluronic acid and other glycosaminoglycan caused by OFs activation, as well as related inflammatory reactions including tissue congestion and edema; inhibit adipocyte cellularization of OFs, thereby reducing the disease activity of patients with active thyroid ophthalmopathy and improving proptosis, diplopia, ocular congestion and edema and other symptoms and signs. The report “ IGF-1R- and IGF-1 Targeted Immunotherapy Pipeline Review ” can be acquired at La Merie Publishing’s online store: https://lamerie.com/report/igf-1r-and-igf-1-targeted-immunotherapy-pipeline-review/ About La Merie Publishing La Merie Publishing is an independent business information provider for the biotechnology and pharmaceutical industry. La Merie Publishing prepares brief and full reports. La Merie Publishing products can be purchased in the online store www.lamerie.com and from selected Resellers. La Merie Publishing offers the service of custom report preparation for corporate clients, including, but not limited to, pipeline analysis reports, drug profiles and any other competitive intelligence elaboration of interest. SOURCE: La Merie Publishing

免疫疗法临床3期临床结果

2023-08-12

·药时代

每年500多亿美元，全打了水漂！癌症临床试验的这条崎岖小径……

500～600亿美元，这是每年癌症临床试验失败所耗费的资金。普通人很难理解这个数字的概念，我们只会感叹：好多啊！却并不能切实的理解它。我们可以简单地做个对比：2022年，制药巨头辉瑞投入了114.3亿美元的研发费用；同样庞大的药企强生投入了143亿美元。就算只用最保守的估计费用——500亿美元来对比，每年癌症临床试验失败的花销大约等于4.5个辉瑞，3.5个强生。这个数字不仅仅意味着每年失败的癌症临床试验很多，也进一步说明了肿瘤领域的火热，所以每年进行的癌症临床试验规模巨大。这也并不难理解。事实上，癌症是中国乃至全世界的一个重要死亡原因，其发病率与死亡率一直居高不下，是对人类健康和生命安全的一大威胁。2020年，将近1000万例患者死于癌症，几乎占世界全部死亡人数的六分之一。此外，根据世界卫生组织的统计，每年有40万儿童罹患癌症。归根究底，癌症的发病率与死亡率这样居高不下的的原因，还是癌症的治疗难度太大。不同于其他疾病，癌症由于其发病的位置、性质等因素的区别，治疗所需药物的靶点、机制也不尽相同。虽然治疗癌症的靶点众多，但是真正能用的、好用的却如凤毛麟角。好靶点的比例较少，各个制药公司和投资公司都趋之若鹜，与此同时，新靶点的的研究也非常火热。高昂的代价2023年7月28日，JAMA Network发布了一篇文章，作者Valerie Jentzsch统计了从2000年1月到2023年7月进行的16种IGF-1R抑制剂的临床试验情况，这16种IGF-1R抑制剂由16家公司分别推进。胰岛素样生长因子1受体(IGF-1R)属于酪氨酸激酶受体家族。其高亲和力配体IGF-1，是一种在分子结构上与多肽类激素胰岛素类似的激素，在生长发育和成人的合成代谢中有重要作用，可引起骨骼肌或其他组织的过度增殖。已发表的IGF-1R 抑制剂的临床前体内数据的调查，详细介绍了所使用的IGF-1R抑制剂、异种移植肿瘤类型、对测定方法的简要观察和结果，同时，用9种IGF-1R抑制剂作为单一药物，针对各种肿瘤异种移植的肿瘤生长抑制百分比的估计值，在注释的62个细胞系结果中，有31个细胞系结果的肿瘤生长抑制率低于50%。基于这个数据，从2003年起，制药行业开始了对IGF-1R 抑制剂的研发的竞争，16种IGF-1R 抑制剂进入了针对多种癌症和多种药物组合的183项临床试验。临床试验结果显示，IGF-1R 抑制剂单独用药时，其毒性在可接受的范围内，而它的联合用药的毒性会更大。例如，Amgen开发的Ganitumab联合激素治疗受体阳性乳腺癌的试验中，与安慰剂组相比，Ganitumab组有25%的受试者出现了不良反应，其中最常见的是3级及以上不良反应事件中性粒细胞减少症。直到现在，这些IGF-1R 抑制剂都未被批准上市用以治疗癌症，不论是作为单药还是联合用药。据Valerie Jentzsch的统计，16种IGF-1R抑制剂在12000多名受试者中进行了临床试验，研发费用总计大约在16亿~23亿美元之间。仅这一种药物的研发失败成本就已经这样高昂，看来每一年临床试验失败耗费的500亿～600亿也不是空穴来风。由于部分被数据的缺失，Valerie Jentzsch使用平均数代替具体数据，估算得到183项IGF-1R抑制剂临床试验的大概费用。图1显示了有具体数据的129项临床试验的研发费用。图1：行业发起的试验估算的 129 项临床试验的研发费用图2 显示了从 2000 年至 2015 年启动的临床试验数量，按1～3期划分。第一个使用单一 IGF-1R 抑制剂 figitumumab 的临床 1 期试验于 2003 年开始，3 期试验于2008 年开始。从 2003 年到 2012 年，每年启动的临床试验数量有增有减，然后从 2013 年起大幅下跌。图2图3显示了每年使用 IGF-1R 抑制剂与其他抗癌药物组合的临床试验数量（按试验阶段细分）。图3因为IGF-1R 抑制剂临床试验的全军覆没，有不少人提出了质疑，但是他们并没有质疑临床前数据预测的IGF-1R 抑制剂的研究价值，而是认为这些研究本身出了问题。如今并没有确凿的证据可以证明IGF-1R 抑制剂的机制有问题，所以IGF-1R 抑制剂的研究大概率不会停下，会有更多的临床试验开启，也必然会有更多的失败和更大的花销。目前普乐康医药的IGF-1R 甲状腺眼药获得了国内的临床试验许可；信达生物的IGF-1R 甲状腺眼药进入三期临床试验。众所周知，新药研发的失败率很高，一个全新领域的探索是不可能没有失败的，而我们想要讨论的，是如此高昂的失败代价是否是有价值。沉舟侧畔2020年1月，FDA批准了其中的一种IGF-1R 抑制剂（Tepezza、teprotumumab；罗氏）用于治疗格雷夫斯病——一种免疫系统障碍疾病。这个结果虽然与研究IGF-1R 抑制剂的目的南辕北辙，但是它仍然可以算作一种成功。只从这一点来看，花费在IGF-1R 抑制剂上的资金就已经不算浪费了。谁都知道，临床试验的失败是无法避免的，但是临床试验本身是绝不能被取缔的。要确定新药的疗效和安全性，进行临床试验是唯一的途径。临床试验产出的大量数据，是探索药物的使用剂量、适应症、疗效和禁忌症的重要基础。但是，难道我们就要一直承担着如此巨大的失败代价，等待一个未知的结果吗？其实，这样巨大规模的失败，本可以避免。这16家公司可能是基于临床前数据预测，开始进行IGF-1R 抑制剂的研究，即使并没有一款真正成功的产品，他们仍然在多家同行的共同前进下，成为了羊群中的一只羊，随波逐流。然而这样的现象在如今的制药行业层出不穷，面对激烈的竞争和癌症药品极大的需求，他们没有太多的时间去进行足够理性的分析。但是16项IGF-1R 抑制剂的全部失败，给我们上了一课：要确定临床前预测的有效性和候选药物在模型中应该满足的标准；避免整个业界对某个技术的偏爱，导致其他机制获得的投资不足，陷入困境。在开启临床实验之前，各家公司是不是也该评估自己的技术、管线、资金是否与那些大热的研究方向所匹配？一些底蕴深厚的大公司都可能在新靶点的研究上栽跟头，更罔论一些盲目跨行来追逐的公司了，他们的失败是必然的。我们当然能理解，热门的、数据好看的机制，会吸引更多的投资者，但是这样的项目一旦失败，影响到的也就不仅仅是项目本身了。制药行业的资源是有限的，天平倾向一边，另一边获得的自然会更少，没有足够资金的项目，又要怎么坚持下去呢。这是一个很难解决的问题，高校的研究所可以获得国家的补助与支持，但是他们的研究速度较慢，追不上瞬息万变的市场需求；企业的研究速度虽然更快，但是他们的资金难以得到保障。或许，国家也可以开通对企业的临床试验补助，支持无力继续试验的项目，在试验成功，产品上市后，要求以更低的价格在国内售卖。或者通过制定一些新的规则，让资本分流，而不是一窝蜂的堆积在某个或某几个项目上。当然，这不是一朝一夕就能做成的事。从现状来看，如今能稍稍减小这个问题对临床试验的压力的措施，只有对临床前研究的数据进行更加详细的分析和评估，更加谨慎的开启临床试验。事实上，临床试验导致的问题不只有白白耗费的资金，这对研究人员，对受试者都是一场灾难。研究人员数年的心血付之一炬，而患者服用了大量疗效无几，毒性未知的药物。这些挫折可能会让许多人放弃继续进行临床试验。综上所述，为了临床试验更好的发展，降低临床试验的失败率迫在眉睫，但是目前却还没有一个行之有效的方法。好在过于庞大的临床试验失败耗费的资金，已经让我们看到了这个问题。而已知的问题，总会有办法解决。参考文献：1.https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2807710?resultClick=32.https://www.dana-farber.org/for-patients-and-families/becoming-a-patient/international-patients/chinese/inspiration/%E4%B8%B4%E5%BA%8A%E8%AF%95%E9%AA%8C%E5%A6%82%E4%BD%95%E6%8E%A8%E5%8A%A8%E7%99%8C%E7%97%87%E7%96%97%E6%B3%95%E7%9A%84%E8%BF%9B%E6%AD%A5clinical-trials/3.https://www.pfizer.com.cn/zh-hans4.https://www.jnj.com.cn/5.其他公开资料封面图来源：123rf美国研发出能杀死所有实体瘤的药物，是不是真的？药时代路演第三期 | 抗体领域龙头企业优质系列双抗对外授权药研之“星”，等你来挑战点击阅读原文，与药时代一起快乐学习！

临床研究申请上市

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外链

KEGG	Wiki	ATC	Drug Bank
D09908	盖尼塔单抗	-	DB12205

研发状态

适应症	最高研发状态	国家/地区	公司
类癌	临床2期	波兰更多	Amgen, Inc. 更多
淋巴瘤	临床2期	西班牙更多	Amgen, Inc. 更多
肉瘤	临床2期	美国更多	Amgen, Inc. 更多
结直肠癌	临床2期	美国更多	Amgen, Inc. 更多
非小细胞肺癌	临床2期	波兰更多	Amgen, Inc. 更多

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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


Pubmed	临床2期	复发性尤文肉瘤	10	Palbociclib 125 mg + Ganitumab 18 mg/kg	(鑰簾襯觸遞廠簾鏇鹽簾) = 艱壓範衊餘願窪製壓齋範窪膚獵窪糧網廠蓋製 (繭醖餘顧鹹餘選鬱餘窪, 1.6 ~ 58.4) 更多	不佳	2023-06-12
NCT00719212 (ASCO2013)	临床2期	铂敏感性卵巢癌二线	61	Ganitumab 18 mg/kg	(鹽範觸淵鏇積鬱鬱糧獵) = 膚製鏇鹽願範願醖鹹糧廠鑰獵壓願鏇鬱餘衊遞 (鹹顧鑰蓋艱鬱壓鹽鹽簾, 2.8 ~ 10.8) 更多	-	2013-05-20
NCT00788957 (20060447, ASCO_GI2015) 人工标引	临床2期	转移性结直肠癌 KRAS Mutation	142	Panitumumab+Rilotumumab (WT KRAS exon 2)	夢構繭蓋鹽獵艱齋艱鬱(夢簾範廠遞鏇範築鏇蓋) = 衊膚淵夢範窪衊鏇醖鬱鬱鹹鏇廠蓋壓顧衊蓋網 (獵範夢繭鹽選構製鹹廠 ) 更多	积极	2015-01-20
NCT00788957 (20060447, ASCO_GI2015) 人工标引	临床2期	转移性结直肠癌 KRAS Mutation	142	Panitumumab+Ganitumab (WT KRAS exon 2)	夢構繭蓋鹽獵艱齋艱鬱(夢簾範廠遞鏇範築鏇蓋) = 壓遞鏇選獵衊製醖繭願鬱鹹鏇廠蓋壓顧衊蓋網 (獵範夢繭鹽選構製鹹廠 ) 更多	积极	2015-01-20
NCT03041701 (ASCO2022) 人工标引	临床1期	横纹肌肉瘤	11	ganitumab+dasatinib	(製製膚夢鏇製鏇壓鏇鏇) = cytopenias and electrolyte abnormalities 鏇壓積範築簾簾艱簾製 (顧膚簾鬱憲鬱窪範遞願 ) 更多	积极	2022-06-02
NCT04129151 (ASCO2022) 人工标引	临床2期	复发性尤文肉瘤	10	palbociclib+ganitumab	(顧餘繭蓋壓鹽願網廠鹽) = 衊鑰壓齋艱窪窪獵鑰簾範鹽積糧蓋艱鏇鑰窪繭 (壓鏇選膚餘鏇膚膚醖遞 ) 更多	不佳	2022-06-02
NCT03041701 (Pubmed)	临床1期	横纹肌肉瘤	14	Ganitumab	(夢夢餘繭構繭觸製遞憲) = 製願廠憲願鹹顧簾淵壓膚壓蓋築遞襯鏇觸糧選 (襯觸顧鬱齋糧窪製壓蓋 )	-	2023-07-03
NCT01024387 (ASCO2012) 人工标引	临床2期	晚期胰腺神经内分泌肿瘤	60	Ganitumab	(壓齋醖鹽選築糧構膚鑰) = 廠遞廠壓遞壓衊餘衊壓築糧蓋築積鏇鹹簾鏇艱 (願範淵獵醖繭窪窪遞淵 ) 更多	不佳	2012-05-20
NCT01042379 (I-SPY2, ASCO2022)	临床2期	三阴性乳腺癌新辅助 gene expression profiling \| Immune enhanced \| Immune-/DNA Repair Deficient	987	Neratinib	(廠鏇襯夢築糧齋淵願鹹) = 膚選淵淵齋繭觸網醖鬱範鹹齋餘夢夢構壓衊襯 (鬱夢蓋襯鏇觸餘鏇壓遞 )	积极	2022-06-02
NCT01042379 (I-SPY2, ASCO2022)	临床2期		987	MK2206	(廠鏇襯夢築糧齋淵願鹹) = 窪鹽願醖觸製壓淵遞淵範鹹齋餘夢夢構壓衊襯 (鬱夢蓋襯鏇觸餘鏇壓遞 )	积极	2022-06-02
Pubmed \| Target Oncol	N/A	-	78	Ganitumab	(齋夢齋廠鹹廠憲鹽繭鹹) = 淵構壓襯醖蓋積淵膚淵範鏇鏇獵淵膚鹹膚遞醖 (夢築壓餘顧選繭鬱觸顧 )	-	2015-03-01
AEWS1221 (Pubmed)	临床3期	尤文肉瘤	-	Ganitumab (Standard arm (VDC/IE))	(鑰憲簾鏇鹹糧構顧觸衊) = 鏇衊鑰鹹願構選醖憲繭願鹹壓廠淵憲鹹廠壓選 (鏇齋憲願膚鑰蓋憲觸蓋, 29.3 ~ 45.5) 更多	不佳	2023-01-20
AEWS1221 (Pubmed)	临床3期	尤文肉瘤	-	Experimental arm (VDC/IE with ganitumab)	(鑰憲簾鏇鹹糧構顧觸衊) = 鬱網餘選觸選範範顧鹹願鹹壓廠淵憲鹹廠壓選 (鏇齋憲願膚鑰蓋憲觸蓋, 31.3 ~ 46.7) 更多	不佳	2023-01-20