A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive, HER-2 Negative Advanced Breast Cancer Patients

A Phase 1, Open label, Dose escalation and Dose expansion study of SCO-120 in HR +ve HER2-ve advanced/ metastatic breast cancer (MBC) patients to evalaute the safety, tolerability and prelimnary efficacy. Initial part with dose escalation is to determine the MTD and RP2D, and PK and PD characterisation. RP2D will be further evalauted for prelimnary efficacy in MBC patients with tretament failure on Aromatase Inhibitor/Fulvestrant/CDK4-6 inhibitors with or with out ESR1 mutation.

开始日期2022-05-20

申办/合作机构

Sun Pharma Advanced Research Co. Ltd.

CTR20202537 / Suspended临床3期

EndoTAG-1联合吉西他滨与吉西他滨单药治疗可测量局部晚期和/或转移性胰腺癌有效性和安全性的多中心、随机、对照、开放、Ⅲ期临床研究

本研究的目的是评价EndoTAG-1联合吉西他滨治疗较之吉西他滨单药治疗局部晚期和/或转移性胰腺癌患者的有效性和安全性

开始日期2021-08-16

申办/合作机构

杏国新药股份有限公司

[+2]

NCT03126435 / Completed临床3期

A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.

开始日期2018-10-16

申办/合作机构

杏国新药股份有限公司

100 项与 EndoTAG-1 相关的临床结果

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100 项与 EndoTAG-1 相关的转化医学

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100 项与 EndoTAG-1 相关的专利（医药）

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项与 EndoTAG-1 相关的文献（医药）

2024-04-01·Molecular pharmaceutics

Sialic Acid Conjugate-Modified Cationic Liposomal Paclitaxel for Targeted Therapy of Lung Metastasis in Breast Cancer: What a Difference the Cation Content Makes

Article

作者: Chen, Guoliang ; Ge, Ruirui ; Wang, Yu ; Han, Chao ; Han, Yingchao ; Sun, Wenliang ; Jiang, Xiaotong ; Yang, Mingshi ; Song, Yanzhi ; Deng, Yihui ; Wang, Ning

Cationic lipids play a pivotal role in developing novel drug delivery systems for diverse biomedical applications, owing to the success of mRNA vaccines against COVID-19 and the Phase III antitumor agent EndoTAG-1. However, the therapeutic potential of these positively charged liposomes is limited by dose-dependent toxicity. While an increased content of cationic lipids in the formulation can enhance the uptake and cytotoxicity toward tumor-associated cells, it is crucial to balance these advantages with the associated toxic side effects. In this work, we synthesized the cationic lipid HC-Y-2 and incorporated it into sialic acid (SA)-modified cationic liposomes loaded with paclitaxel to target tumor-associated immune cells efficiently. The SA-modified cationic liposomes exhibited enhanced binding affinity toward both RAW264.7 cells and 4T1 tumor cells in vitro due to the increased ratios of cationic HC-Y-2 content while effectively inhibiting 4T1 cell lung metastasis in vivo. By leveraging electrostatic forces and ligand-receptor interactions, the SA-modified cationic liposomes specifically target malignant tumor-associated immune cells such as tumor-associated macrophages (TAMs), reduce the proportion of cationic lipids in the formulation, and achieve dual objectives: high cellular uptake and potent antitumor efficacy. These findings highlight the potential advantages of this innovative approach utilizing cationic liposomes.

2024-03-04·Current pharmaceutical biotechnology

Nanotheranostics: A Cutting-Edge Technology for Cancer Management

Article

作者: Swain, Shasank Sekhar ; Dash, Shwetapadma ; Sahoo, Sanjeeb Kumar ; Dutta, Sneha ; Khuntia, Auromira

Abstract::

Cancer is the second-leading cause of death in the 21st century, where early detection and appropriate therapeutic interventions are two components essential for effective cancer management. Despite the availability of several conventional diagnostics and therapeutic agents, cancer mortality rates are rising due to an increase in the frequency of recurrence and metastasis in cancer patients. Therefore, tremendous efforts have been expended to address this significant clinical issue and improve therapeutic efficacy. In this regard, nanotheranostic is a multipotential single platform for both cancer diagnosis and treatment through enhanced aqueous solubility and bioavailability of the encapsulated agent, stimulus responsiveness, tumor-specific targeting ability, precise tumor imaging, and real-time drug delivery. Nonetheless, the translational success of nanotheranostic platforms is still in its infancy and requires more extensive research in the context of tumor heterogeneity, safety profile, and regulatory issues, which pose one of the largest technological limitations. The present review summarizes different nanotheranostic platforms and nanotheranostic candidates in clinical trials (AGuIX® , NBTXR3, Ferumoxtran, MM-398, EndoTAG-1, etc.), along with disadvantages and challenges to improving cancer diagnosis and treatment. Overall, the concept, platform, and technical knowledge of nanotheranostics are really helpful to academic and pharmaceutical researchers.

2022-12-28·ACS applied materials & interfaces

Paclitaxel-Loaded Cationic Fluid Lipid Nanodiscs and Liposomes with Brush-Conformation PEG Chains Penetrate Breast Tumors and Trigger Caspase-3 Activation

Article

作者: Ewert, Kai K. ; Teesalu, Tambet ; Fisher, William S. ; Sidorenko, Valeria ; Scodeller, Pablo ; Steffes, Victoria M. ; Safinya, Cyrus R. ; Simón-Gracia, Lorena

Novel approaches are required to address the urgent need to develop lipid-based carriers of paclitaxel (PTX) and other hydrophobic drugs for cancer chemotherapy. Carriers based on cationic liposomes (CLs) with fluid (i.e., chain-melted) membranes (e.g., EndoTAG-1) have shown promise in preclinical and late-stage clinical studies. Recent work found that the addition of a cone-shaped poly(ethylene glycol)-lipid (PEG-lipid) to PTX-loaded CLs (CLs_PTX) promotes a transition to sterically stabilized, higher-curvature (smaller) nanoparticles consisting of a mixture of PEGylated CLs_PTX and PTX-containing fluid lipid nanodiscs (nanodiscs_PTX). These CLs_PTX and nanodiscs_PTX show significantly improved uptake and cytotoxicity in cultured human cancer cells at PEG coverage in the brush regime (10 mol % PEG-lipid). Here, we studied the PTX loading, in vivo circulation half-life, and biodistribution of systemically administered CLs_PTX and nanodiscs_PTX and assessed their ability to induce apoptosis in triple-negative breast-cancer-bearing immunocompetent mice. We focused on fluid rather than solid lipid nanodiscs because of the significantly higher solubility of PTX in fluid membranes. At 5 and 10 mol % of a PEG-lipid (PEG5K-lipid, molecular weight of PEG 5000 g/mol), the mixture of PEGylated CLs_PTX and nanodiscs_PTX was able to incorporate up to 2.5 mol % PTX without crystallization for at least 20 h. Remarkably, compared to preparations containing 2 and 5 mol % PEG5K-lipid (with the PEG chains in the mushroom regime), the particles at 10 mol % (with PEG chains in the brush regime) showed significantly higher blood half-life, tumor penetration, and proapoptotic activity. Our study suggests that increasing the PEG coverage of CL-based drug nanoformulations can improve their pharmacokinetics and therapeutic efficacy.

项与 EndoTAG-1 相关的新闻（医药）

2023-05-31

·BioSpace

IDgenetix® Shown to Significantly Improve Medication Response and Remission Rates in Patients with Major Depressive Disorder

In the study, patients whose medication management was guided by IDgenetix achieved a 35% increase in medication response and a 64% increase in remission compared to patients whose medication was not guided by the test FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced real-world study data demonstrating that use of IDgenetix® to guide medication management can significantly improve medication response and remission rates in patients diagnosed with moderate to severe depression, compared to current standard-of-care treatment. The data was shared via a poster presentation at the May 2023 American Psychiatric Association (APA) Annual Meeting held in San Francisco. “Unlike other pharmacogenomic tests, which only consider a patient’s drug-gene interactions, IDgenetix takes into account a patient’s drug-drug interactions and lifestyle factors, and can provide a more comprehensive overview of which medications will be effective therapies for the patient,” said Kelly Wosnik, DNP, NP-C, owner and nurse practitioner at Bristol Health, and co-author of the study. “As supported by the data in this study, using IDgenetix to guide personalized medication selection can help improve the care of patients suffering from moderate to severe depression by offering hope of improved medication response and remission.” In the study, patients whose medication management was guided by IDgenetix achieved a 35% increase in medication response and a 64% increase in remission rate at eight weeks compared to patients whose medication was not guided by the test. These results demonstrate the potential value of IDgenetix in guiding improved medication management compared to the standard-of-care, trial-and-error approach, and are consistent with the previously published randomized control trial (RCT) using IDgenetix.1 The study abstract can be accessed via APA’s website here. IDgenetix is Castle’s next-generation pharmacogenomic (PGx) test that incorporates the results of a 15-gene variant panel with drug-drug interaction data and lifestyle factors to provide medication recommendations for patients with mental health conditions, such as depression and anxiety. Using the IDgenetix test report, clinicians may be able to more precisely tailor treatments to individual patients, rather than relying on trial and error, potentially reducing the chances of side effects or ineffective treatments. In an RCT, patients diagnosed with severe depression whose medication management was guided by the IDgenetix test showed a greater than two and a half times improvement in remission rates at eight and 12 weeks compared to those who were not guided by IDgenetix.1 About IDgenetix® IDgenetix® is a pharmacogenomic (PGx) product test for depression, anxiety and other mental health conditions designed to analyze a patient’s genetic make-up to guide timely and evidence-based decisions on the optimal drug for each patient. IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard-of-care, trial-and-error approach. IDgenetix provides drug-drug and drug-gene interactions and is supported by a published, peer-reviewed randomized controlled trial that demonstrated clinical utility over the standard of care when physicians used IDgenetix prior to prescribing a medication. More information about Castle’s tests can be found at . About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit and connect with us on LinkedIn, Facebook, Twitter and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of IDgenetix to (i) significantly improve medication response and remission rates in patients diagnosed with moderate to severe depression compared to current standard of care treatment; (ii) provide a more comprehensive overview of which medications will be effective therapies for the patient; (iii) help improve the care of patients suffering from moderate to severe depression by offering hope of improved medication response and remission rate; (iv) add value by guiding improved medication management compared to the standard-of-care, trial-and-error approach; and (v) enable clinicians to more precisely tailor treatments to individual patients, rather than relying on trial and error, potentially reducing the chances of side effects or ineffective treatments. The words “can,” “may,” “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results shown in this study, including with respect to the discussion of IDgenetix in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. 1. Bradley P, Shiekh M, Mehra V, et al. Improved efficacy with targeted pharmacogenetic-guided treatment of patients with depression and anxiety: A randomized clinical trial demonstrating clinical utility. J Psychiatr Res. 2018 Jan;96:100-107. doi: 10.1016/j.jpsychires.2017.09.024. Epub 2017 Sep 23. PMID: 28992526.

临床结果临床研究

100 项与 EndoTAG-1 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期胰腺腺癌	临床3期	美国	杏国新药股份有限公司	2018-10-16
局部晚期胰腺腺癌	临床3期	法国	杏国新药股份有限公司	2018-10-16
局部晚期胰腺腺癌	临床3期	匈牙利	杏国新药股份有限公司	2018-10-16
局部晚期胰腺腺癌	临床3期	以色列	杏国新药股份有限公司	2018-10-16
局部晚期胰腺腺癌	临床3期	俄罗斯	杏国新药股份有限公司	2018-10-16
局部晚期胰腺腺癌	临床3期	韩国	杏国新药股份有限公司	2018-10-16
局部晚期胰腺腺癌	临床3期	中国台湾	杏国新药股份有限公司	2018-10-16
胰腺腺癌	临床3期	美国	杏国新药股份有限公司	2018-10-16
胰腺腺癌	临床3期	法国	杏国新药股份有限公司	2018-10-16
胰腺腺癌	临床3期	匈牙利	杏国新药股份有限公司	2018-10-16

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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


NCT03126435 (CTgov)	临床3期	胰腺腺癌 \| 胰腺继发性恶性肿瘤 \| 局部晚期胰腺腺癌	218	Gemcitabine+EndoTAG-1 (EndoTAG-1 and Gemcitabine)	膚願構齋選鏇窪鑰鹹鏇(獵廠夢糧鏇壓構製願膚) = 願獵築繭夢鹹構膚窪構膚願憲鑰糧餘醖構築鹹 (憲夢鬱艱積衊齋醖鹹鏇, 憲鬱網夢齋繭糧鬱繭鏇 ~ 壓糧膚簾繭鏇網窪築網) 更多	-	2023-03-24
				Gemcitabine (Gemcitabine Monotherapy)	膚願構齋選鏇窪鑰鹹鏇(獵廠夢糧鏇壓構製願膚) = 蓋膚鏇觸築願醖憲廠餘膚願憲鑰糧餘醖構築鹹 (憲夢鬱艱積衊齋醖鹹鏇, 構鹹鬱齋繭襯鹽網願繭 ~ 築觸鬱積鹽淵蓋顧齋網) 更多
ESMO_ASIA2022	临床3期	胰腺腺癌二线	218	EndoTAG-1 plus gemcitabine	鬱糧觸淵糧積觸艱廠願(觸壓構築膚觸鑰壓襯淵) = 淵簾願範膚遞襯網構選襯鹽選糧艱壓構夢淵築 (鏇簾壓淵鹽積範顧繭遞 ) 更多	不佳	2022-12-03
				Gemcitabine alone	鬱糧觸淵糧積觸艱廠願(觸壓構築膚觸鑰壓襯淵) = 築膚範範廠網衊鹽積選襯鹽選糧艱壓構夢淵築 (鏇簾壓淵鹽積範顧繭遞 ) 更多