A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in 270 patients with advanced cancer that has recurred/progressed.

开始日期2022-06-24

申办/合作机构

AstraZeneca PLC

NCT02898662 / Completed临床2期

A Phase 2 Placebo-Controlled, Randomized, Double Blind, Adaptive Dose Trial of the Safety and Efficacy of Inhaled AZD1419 in Adults With Eosinophilic, Moderate to Severe Asthma

Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark, Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized patients with eosinophilic, moderate to severe asthma. The patients will receive 13 once weekly inhaled doses of the study drug. Treatment is initiated on top of their ICS/LABA controller medication, which is then tapered down and withdrawn during a period of 3 weeks and during the last 3 weeks of treatment the study drug is given as monotherapy. SABA is used as reliever medication during the whole study period. Primary endpoint is Loss of asthma control. When the endpoint is met, patients will resume their ICS/LABA, will be followed for an additional 4 weeks and will thereafter discontinue the study.

开始日期2016-10-12

申办/合作机构

AstraZeneca PLC

EUCTR2016-000977-19-DK / Not yet recruiting临床2期

A Phase 2 Placebo-Controlled, Randomized, Double Blind, Adaptive Dose Trial of the Safety and Efficacy of Inhaled AZD1419 in Adults With Eosinophilic, Moderate to Severe Asthma

开始日期2016-09-21

申办/合作机构

AstraZeneca AB

100 项与 AZD-1419 相关的专利（医药）

登录后查看更多信息

项与 AZD-1419 相关的文献（医药）

2021-02-01·American journal of respiratory and critical care medicine1区 · 医学

A Phase 2a, Double-Blind, Placebo-controlled Randomized Trial of Inhaled TLR9 Agonist AZD1419 in Asthma.

1区 · 医学

Article

作者: Ioannis Psallidas ; Vibeke Backer ; Piotr Kuna ; Robert Palmér ; Sofia Necander ; Malin Aurell ; Katarina Korsback ; Ziad Taib ; Mahdi Hashemi ; Per Gustafson ; Sara Asimus ; Stephen Delaney ; Katerina Pardali ; Fanyi Jiang ; Joachim Almquist ; Sam Jackson ; Robert L Coffman ; David Keeling ; Tariq Sethi

Rationale: To examine the potential of TLR9 (Toll-like receptor 9) activation to modulate the type 2 immune response in asthma.Objectives: To evaluate efficacy and safety of AZD1419, an inhaled TLR9 agonist, in a phase 2a, randomized, double-blind trial.Methods: Adult patients with asthma with a history of elevated eosinophils (>250 cells/μl) were randomized 1:1 to receive 13 once-weekly doses of inhaled AZD1419 (1, 4, or 8 mg; n = 40) or placebo (n = 41). Inhaled corticosteroids and long-acting β₂-agonist were tapered down and then discontinued. The last four doses of AZD1419 were given without maintenance medication, followed by a 40-week observation period. Primary endpoint was time to loss of asthma control (LOC).Measurements and Main Results: AZD1419 induced a T-helper cell type 1-type IFN response with a sustained reduction in markers of type 2 inflammation. However, there were no statistically significant differences between AZD1419 and placebo for time to LOC, proportion of patients with LOC, changes in Asthma Control Questionnaire-five-item version, exacerbations, reliever use, FEV₁, peak expiratory flow, or fractional exhaled nitric oxide (Fe_NO). LOC was predicted by an early rise in Fe_NO in 63% of patients. Despite withdrawal of maintenance treatment, 24 patients completed the study without LOC; AZD1419 n = 11, placebo n = 13. Adverse events were balanced across groups, with no deaths or serious adverse events judged as causally related to AZD1419.Conclusions: AZD1419 was safe and well tolerated but did not lead to improved asthma control, despite reducing markers of type 2 inflammation. Results suggest that a novel accelerated step-down approach based on Fe_NO is possible for patients with well-controlled asthma.

2018-08-01·Clinical pharmacology and therapeutics2区 · 医学

First-in-Human Study With the Inhaled TLR9 Oligonucleotide Agonist AZD1419 Results in Interferon Responses in the Lung, and Is Safe and Well-Tolerated.

2区 · 医学

Article

作者: Sam Jackson ; Albert F Candia ; Stephen Delaney ; Simone Floettmann ; Clifford Wong ; John D Campbell ; Sariah Kell ; Jeremy Lum ; Edith M Hessel ; Paula Traquina ; Mark McHale ; Ian Robinson ; John Bell ; Rainard Fuhr ; David Keeling ; Robert L Coffman

Current asthma treatments address symptoms rather than the underlying disease pathophysiology, a better understanding of which has led to the identification of the Th2 high endotype. The activation of Toll-like receptors to induce Type I interferons directly in the lungs represents a novel therapeutic approach to reset this underlying Th2 pathophysiology with the potential to provide long-term disease modification. We present the nonclinical data and phase I clinical profile of an inhaled TLR9 agonist, AZD1419, a C-type CpG designed to induce interferon in the lung. In healthy volunteers, AZD1419 was found to be safe and well-tolerated. Target engagement in the lung was demonstrated at all dose levels tested. No evidence of tolerization or amplification of responses was evident on repeated dosing and 15.4 mg was defined as the maximum tolerated dose. AZD1419 clinical data supports its continued development as a potentially disease-modifying therapeutic in asthma.

项与 AZD-1419 相关的新闻（医药）

2011-12-21

·BioSpace

Dynavax Technologies Corporation and AstraZeneca PLC Agree to Conduct Toxicology Studies for TLR-9 Agonist for Asthma

BERKELEY, CA--(Marketwire - December 21, 2011) - Dynavax Technologies Corporation (NASDAQ: DVAX) and AstraZeneca announced today their decision to advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into IND-enabling preclinical toxicology studies. These toxicology studies are scheduled to be the first module of work performed by Dynavax under the recently amended collaboration agreement for the clinical development of AZD1419. Development expenses will be fully funded by AstraZeneca, and Dynavax will receive payment of $2.6 million to begin the studies. About AZD1419 AZD1419 has been selected as the lead clinical candidate to enter formal clinical development based on extensive preclinical studies conducted by Dynavax and AstraZeneca. These include demonstration that AZD1419 is capable of producing long lasting disease-modifying effects in a mouse model of atopic asthma. Under the terms of the amended 2006 research collaboration and license agreement, AstraZeneca will provide to Dynavax approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a. If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product. Additional remaining milestone payments to Dynavax amount to nearly $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States. About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit . Forward Looking Statements This press release contains "forward-looking statements," including statements related to expected payments under our AstraZeneca agreement and the potential features of the Company's TLR-9 agonists. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether results of completed studies can be replicated in human studies, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our AstraZeneca agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in the Company's current periodic reports with the SEC. Contact: Michael Ostrach Vice President and Chief Business Officer 510-665-7257 Email Contact

疫苗

研发状态

适应症	最高研发状态	国家/地区	公司
哮喘	终止	瑞典更多	AstraZeneca PLC 更多
慢性阻塞性肺疾病	终止	美国更多	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02898662 (CTgov)	临床2期	肺嗜酸性粒细胞增多 \| 哮喘	81	AZD1419 (AZD1419)	願觸淵選淵窪夢構衊蓋(築壓壓觸窪範壓夢願衊) = 築築齋鹹蓋簾遞製糧鑰衊積夢淵廠繭簾蓋壓蓋 (鏇鏇憲繭簾壓築糧餘遞, 齋醖鑰艱鬱製築網鹽艱 ~ 廠範製範衊壓憲觸遞淵) 更多	-	2019-10-21
				Placebo (Placebo)	願觸淵選淵窪夢構衊蓋(築壓壓觸窪範壓夢願衊) = 構願衊範襯觸觸鏇選製衊積夢淵廠繭簾蓋壓蓋 (鏇鏇憲繭簾壓築糧餘遞, 繭鬱壓醖鹹網餘淵衊繭 ~ 選衊鑰鹽選糧構膚蓋糧) 更多