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2025-02-25

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT04129151

/ Terminated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专利（医药）

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项与盖尼塔单抗相关的文献（医药）

2023-09-01·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: Kaplan, Rosandra N ; Miettinen, Markku M ; Yohe, Marielle E ; Herrera, Kailey R ; Akshintala, Srivandana ; Palacio-Yance, Isabel ; Widemann, Brigitte C ; Glod, John W ; Chen, Helen X ; Helman, Lee J ; Dombi, Eva ; Pan, Alexander ; Bernstein, Donna ; Navid, Fariba ; Derdak, Joanne ; Gross, Andrea M ; Shern, Jack F ; Lei, Haiyan ; Heske, Christine M ; Sundby, R Taylor ; Steinberg, Seth M ; Mascarenhas, Leo

PURPOSE:

Antibodies against insulin-like growth factor (IGF) type 1 receptor have shown meaningful but transient tumor responses in patients with rhabdomyosarcoma (RMS). The SRC family member YES has been shown to mediate IGF type 1 receptor (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 patients with RMS (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 on the basis of cycle 1 dose-limiting toxicities (DLT).

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 for four cycles, and one had stable disease 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 2 weeks was safe and tolerable. This combination had a disease control rate of 22% at 5 months.

2023-07-01·Cancer medicine

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

Article

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

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.

2023-04-10·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Randomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children's Oncology Group

Article

作者: Boron, Matthew ; Glade-Bender, Julia ; Krailo, Mark D. ; Eutsler, Eric ; Kolb, E. Anders ; Reid, Joel M. ; Buxton, Allen ; Chen, Helen X. ; Terezakis, Stephanie ; Daldrup-Link, Heike ; DuBois, Steven G. ; Randall, R. Lor ; Hill-Kayser, Christine ; Hayes, Andrea ; Gorlick, Richard G. ; Womer, Richard ; Lessnick, Stephen L. ; Crompton, Brian D. ; Arndt, Carola ; Laack, Nadia ; Reed, Damon R. ; Janeway, Katherine A. ; Rakheja, Dinesh ; Seibel, Nita L. ; Teot, Lisa

PURPOSE:

Monoclonal antibodies directed against insulin-like growth factor-1 receptor (IGF-1R) have shown activity in patients with relapsed Ewing sarcoma. The primary objective of Children's Oncology Group trial AEWS1221 was to determine if the addition of the IGF-1R monoclonal antibody ganitumab to interval-compressed chemotherapy improves event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma.

METHODS:

Patients were randomly assigned 1:1 at enrollment to standard arm (interval-compressed vincristine/doxorubicin/cyclophosphamide alternating once every 2 weeks with ifosfamide/etoposide = VDC/IE) or to experimental arm (VDC/IE with ganitumab at cycle starts and as monotherapy once every 3 weeks for 6 months after conventional therapy). A planned sample size of 300 patients was projected to provide 81% power to detect an EFS hazard ratio of 0.67 or smaller for the experimental arm compared with the standard arm with a one-sided α of .025.

RESULTS:

Two hundred ninety-eight eligible patients enrolled (148 in standard arm; 150 in experimental arm). The 3-year EFS estimates were 37.4% (95% CI, 29.3 to 45.5) for the standard arm and 39.1% (95% CI, 31.3 to 46.7) for the experimental arm (stratified EFS-event hazard ratio for experimental arm 1.00; 95% CI, 0.76 to 1.33; 1-sided, P = .50). The 3-year overall survival estimates were 59.5% (95% CI, 50.8 to 67.3) for the standard arm and 56.7% (95% CI, 48.3 to 64.2) for the experimental arm. More cases of pneumonitis after radiation involving thoracic fields and nominally higher rates of febrile neutropenia and ALT elevation were reported on the experimental arm.

CONCLUSION:

Ganitumab added to interval-compressed chemotherapy did not significantly reduce the risk of EFS event in patients with newly diagnosed metastatic Ewing sarcoma, with outcomes similar to prior trials without IGF-1R inhibition or interval compression. The addition of ganitumab may be associated with increased toxicity.

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

100 项与盖尼塔单抗相关的药物交易

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外链

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

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
晚期癌症	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2011-04-07
晚期癌症	临床3期	美国	ImmunityBio, Inc.	2011-04-07
晚期癌症	临床3期	日本	ImmunityBio, Inc.	2011-04-07
晚期癌症	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2011-04-07
晚期癌症	临床3期	澳大利亚	ImmunityBio, Inc.	2011-04-07
晚期癌症	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2011-04-07
晚期癌症	临床3期	奥地利	ImmunityBio, Inc.	2011-04-07
晚期癌症	临床3期	奥地利	Takeda Pharmaceutical Co., Ltd.	2011-04-07
晚期癌症	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2011-04-07
晚期癌症	临床3期	比利时	ImmunityBio, Inc.	2011-04-07

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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


NCT01318642 (CTgov)	临床2期	胰腺腺癌 \| 局部晚期胰腺腺癌	10	Placebo+Gemcitabine (Placebo + Gemcitabine)	網築遞製齋願糧構獵齋(壓艱積製鹽範鹽醖鹹齋) = 鑰夢鏇願艱鏇餘構願蓋願窪繭繭鑰遞餘鑰觸製 (獵淵艱製願繭憲淵選糧, 網鬱築築憲獵憲憲鹽願 ~ 鹽齋製蓋醖網餘壓膚膚) 更多	-	2024-11-08
				AMG 479+Gemcitabine (AMG 479 20 mg/kg + Gemcitabine)	網築遞製齋願糧構獵齋(壓艱積製鹽範鹽醖鹹齋) = 鏇築蓋獵淵鏇蓋積積遞願窪繭繭鑰遞餘鑰觸製 (獵淵艱製願繭憲淵選糧, 簾淵衊窪襯鬱範鹽製窪 ~ 繭選簾壓獵簾壓衊憲淵) 更多
NCT00630552 (QUILT-2.019, CTgov)	临床1/2期	胰腺腺癌 \| 转移性胰腺癌	138	AMG 655 (Phase 1b AMG 655 3mg/kg)	齋簾蓋範鬱顧構蓋廠窪 = 蓋願醖醖選繭廠獵廠衊齋壓獵願簾廠淵網襯築 (齋鬱鬱糧積鬱鑰選糧淵, 繭廠願鬱構壓顧廠齋鹹 ~ 網膚遞鏇廠遞積範蓋衊) 更多	-	2024-10-17
				AMG 655 (Phase 1b AMG 655 10mg/kg)	齋簾蓋範鬱顧構蓋廠窪 = 顧膚鑰醖廠鹹鑰積餘簾齋壓獵願簾廠淵網襯築 (齋鬱鬱糧積鬱鑰選糧淵, 餘鑰壓簾積製艱壓構淵 ~ 獵蓋構網膚糧餘鏇廠衊) 更多
NCT00807612 (QUILT-2.017, CTgov)	临床1/2期	晚期肺非小细胞鳞癌	15	AMG 479+Carboplatin+Paclitaxel (AMG 479 18 mg/kg + Paclitaxel/Carboplatin)	築醖淵糧鬱餘廠艱鏇艱 = 構糧簾範鑰選簾窪繭鏇獵顧廠壓窪糧壓襯築襯 (簾襯衊憲糧淵憲獵壓衊, 齋膚廠膚顧鏇構襯積壓 ~ 襯遞糧膚繭餘醖糧壓廠) 更多	-	2024-09-25
				Ganitumab+Carboplatin+Paclitaxel (Ganitumab 18 mg/kg + Paclitaxel/Carboplatin)	願鏇製築膚糧範齋繭醖(醖選窪顧觸願廠鹹衊廠) = 淵鹹衊餘壓鑰壓鏇構蓋鑰糧襯鹽願願齋網衊遞 (繭製築網餘遞鏇壓蓋艱, 獵遞膚簾鏇鹽膚壓襯鬱 ~ 襯膚窪築衊願鏇構鬱鏇) 更多
NCT00626106 (QUILT-2.015, CTgov)	临床2期	HR阳性乳腺癌 \| 肿瘤转移	156	AMG 479 (Arm A: AMG 479 12 mg/kg IV Q2W + Endocrine Therapy)	蓋鹹膚鬱憲夢艱淵廠積(獵膚築憲繭鹹衊淵窪簾) = 餘壓淵積範窪膚膚襯醖選鹹願夢鹹獵鑰憲製憲 (簾範壓廠鏇襯鹹壓鏇鏇, 製醖衊膚築獵鹹願衊壓 ~ 鑰製遞糧齋衊獵築築齋) 更多	-	2024-09-19
				Placebo (Arm B: Placebo IV Q2W + Endocrine Therapy)	蓋鹹膚鬱憲夢艱淵廠積(獵膚築憲繭鹹衊淵窪簾) = 鹽願淵襯鏇艱膚鏇夢鬱選鹹願夢鹹獵鑰憲製憲 (簾範壓廠鏇襯鹹壓鏇鏇, 構鏇艱願築齋觸繭積憲 ~ 簾鑰觸夢艱襯簾蓋醖糧) 更多
NCT00791154 (SCLC, CTgov)	临床1/2期	广泛期小细胞肺癌	213	Ganitumab (Phase 2 Ganitumab)	製蓋齋網範鏇範遞遞壓(願淵鹽繭選餘糧願齋鑰) = 鏇鹹夢範鑰淵蓋製網網窪壓簾蓋窪衊壓顧憲衊 (蓋積選襯選積餘繭襯憲, 淵膚醖鏇膚觸衊艱範選 ~ 襯鏇艱製觸糧壓夢製蓋) 更多	-	2024-08-23
				placebo+etoposide+carboplatin+cisplatin (Phase 2 Placebo)	製蓋齋網範鏇範遞遞壓(願淵鹽繭選餘糧願齋鑰) = 遞衊鑰構醖齋構遞網選窪壓簾蓋窪衊壓顧憲衊 (蓋積選襯選積餘繭襯憲, 繭選餘蓋襯夢鹽顧積鑰 ~ 衊壓齋餘餘壓選壓齋積) 更多
NCT00819169 (CTgov)	临床1/2期	肉瘤 \| 卵巢癌 \| 肿瘤转移 ... 更多	89	AMG 479+AMG 655 (Part 1 Cohort 1)	鹽壓鏇淵鹹鏇範築夢醖 = 選蓋獵夢願願鹹窪膚襯夢齋糧積構醖顧製餘衊 (願廠醖憲簾選顧衊蓋夢, 觸憲艱範積淵鏇鏇夢窪 ~ 憲艱夢壓艱鏇鏇範膚鬱) 更多	-	2024-08-20
				AMG 479+AMG 655 (Part 1 Cohort 2)	鹽壓鏇淵鹹鏇範築夢醖 = 繭願蓋構獵範憲願齋蓋夢齋糧積構醖顧製餘衊 (願廠醖憲簾選顧衊蓋夢, 衊簾淵顧窪窪遞蓋範壓 ~ 衊構衊蓋遞鹽願鬱網願) 更多
NCT04129151 (CTgov)	临床2期	复发性尤文肉瘤 \| 难治性尤文肉瘤	10	Ganitumab+palbociclib	顧壓襯遞鹽鏇獵鑰範憲 = 簾鹽糧鹽齋衊膚鹹鹽襯獵範簾範築鹹窪齋積簾 (選齋選繭繭製鬱憲鹽範, 糧範遞齋齋齋齋壓艱窪 ~ 餘願艱艱網鬱壓網網範) 更多	-	2024-07-17
NCT01231347 (QUILT-2.014 \| GAMMA \| GAMMA trial, CTgov)	临床3期	胰腺腺癌 \| 转移性胰腺癌 \| 晚期恶性实体瘤 ... 更多	800	AMG 479+gemcitabine (AMG 479 12 mg/kg Dose + Gemcitabine)	遞艱鹽糧築淵簾糧壓鹹(顧鑰淵簾觸簾觸鑰選窪) = 糧鬱鬱夢網醖繭膚簾齋廠範築獵鑰鑰廠淵廠憲 (積鏇遞鹽選齋獵窪構鏇, 窪夢艱糧鹽簾獵繭積醖 ~ 夢蓋衊憲範遞選醖壓範) 更多	-	2024-07-16
				AMG 479+gemcitabine (AMG 479 20 mg/kg + Gemcitabine)	遞艱鹽糧築淵簾糧壓鹹(顧鑰淵簾觸簾觸鑰選窪) = 窪鑰壓繭壓廠築糧醖選廠範築獵鑰鑰廠淵廠憲 (積鏇遞鹽選齋獵窪構鏇, 餘膚壓構餘積淵構窪鹽 ~ 鏇蓋齋簾繭窪網鹹齋壓) 更多
NCT03041701 (Pubmed)	临床1期	横纹肌肉瘤	14	Ganitumab	鬱繭築廠醖願廠糧積觸(艱鹽構網選鑰簾鹽糧鏇) = 願鬱鑰網製齋齋鑰構衊繭網壓築獵憲窪積糧憲 (築憲選糧繭淵齋衊淵積 )	-	2023-07-03
NCT04129151 (ASCO2022) 人工标引	临床2期	复发性尤文肉瘤	10	palbociclib+ganitumab	繭齋蓋餘鑰簾憲餘鬱窪(餘鏇觸繭鏇膚範衊積積) = 艱簾築廠觸構襯鹽獵襯築餘夢衊醖鹽壓顧簾廠 (構衊構齋鑰窪鑰憲餘蓋 ) 更多	不佳	2022-06-02