作者: Nemunaitis, John J. ; Anderson, Gavin ; Hart, Jessica ; Charles, John ; Mita, Alain C. ; Sarantopoulos, John ; Gallegos, Nicole S. ; Sankhala, Kamalesh ; Malik, Laeeq ; Kousba, Ahmed ; Rogers, Jon M. ; Senzer, Neil N. ; Weitman, Steven ; Mahalingam, Devalingam

PURPOSE:

ATI-1123 is a liposomal formulation of docetaxel and may be administered without the premedications and hypersensitivity reactions. This Phase I study examines the safety, tolerability, pharmacokinetics (PKs), and antitumor activity of ATI-1123.

METHODS:

Patients with advanced solid malignancies received escalating doses of ATI-1123 intravenously over 1-h every 3 weeks. The dosing commenced using an accelerated titration design and was followed by a modified 3 + 3 Fibonacci schema to determine maximally tolerated dose (MTD). Plasma was analyzed for encapsulated/non-encapsulated docetaxel; PK analyses were performed using model independent method. Response was assessed using RECIST criteria.

RESULTS:

In total, 29 patients received doses ranging from 15 to 110 mg/m(2). At 110 mg/m(2), two of six patients experienced dose-limiting toxicities including grade 3 stomatitis and febrile neutropenia. The 90 mg/m(2) cohort was expanded to ten patients and identified as the MTD. The most common adverse events were fatigue, nausea, neutropenia, anemia, anorexia, and diarrhea. ATI-1123 exhibited linear and dose proportional PKs. One patient with lung cancer had confirmed partial response, and stable disease was observed in 75 % patients.

CONCLUSIONS:

ATI-1123 demonstrated an acceptable tolerability and favorable PK profile in patients with solid tumors. Our results provide support for Phase II trials to determine the antitumor activity of this drug.

项与多西他赛脂质体(东曜药业) 相关的新闻（医药）

2025-12-03

·分子检测与治疗前沿

携手共赢丨长三角肺癌与知名药企临床研究合作成果阶段汇总

申康党委系统医务专家廖美琳：勇当中国肺癌研究领域排头兵写意人物丨陆舜教授：从PI的角度看中国创新药的发展陆舜教授：有的放矢，做肺癌研究领域的“领潮儿” 陆舜教授：沃利替尼有望成为首个代表中国走向全球的肺癌靶向创新药物陆舜：引领中国抗肿瘤药物研发，将肺癌变成慢性病他的愿望：让肺癌变成慢性病——访上海市胸科医院肿瘤科主任陆舜教授医语舜间丨记录陆舜教授肺癌诊疗领域30余年的精彩瞬间上海交通大学附属胸科医院陆舜教授团队肺癌国内外适应症相关研究阶段汇总推动行业前行的力量-十大医学创新专家推动行业前行的力量-十大医学新锐致敬经典，传承未来丨中国胸部肿瘤原创临床研究二十年心路历程（2007-2029）迎难而上丨中国胸部肿瘤临床试验转化研究长三角模式探索长三角肺癌团魂丨中国胸部肿瘤临床试验转化研究长三角模式探索迎难而上的亮剑精神胸部肿瘤 “工业革命” 成果阶段汇总丨中国胸部肿瘤临床试验转化研究长三角模式探索江浙沪地区历届重要肺癌论坛汇总（长三角地区肺癌论坛系列）传承与发展丨长三角肺癌代表性著作汇总传承与发展丨长三角肺癌协作组指南/专家共识汇总读书笔记丨长三角肺癌科技成果奖励阶段汇总直播课丨长三角肺癌协作组-罕见靶点临床试验招募全国巡讲系列汇总光荣榜丨长三角肺癌协作组陆舜教授团队历届国际会议大会发言汇总长三角肺癌协作组青年博士团队组织框架介绍长三角肺癌之光丨星星之火可以燎原-基层肺癌协作组的前世今生共谋江苏省基层医院肺癌未来发展之路齐聚浙江嘉兴，长三角肺癌再续新篇章——浙江省基层肺癌协作组成立长三角肺癌之光丨金陵肺癌传承与发展长三角肺癌之光丨浙江肺癌传承与发展长三角肺癌之光丨南昌肺癌传承与发展杭州肺癌之光丨嘉兴肺癌（杭州肺癌-嘉兴支）传承与发展杭州肺癌之光丨湖州肺癌（杭州肺癌-湖州支）传承与发展杭州肺癌之光丨台州肺癌（杭州肺癌-台州支）传承与发展走进中国科学院大学附属肿瘤医院（浙江省肿瘤医院）I期临床试验病房长三角实体瘤病友交流群系列全面上线时代背景赶潮儿（1999-2009） 1999年，中国国家食品药品监督管理总局（CFDA）成立，中国自此有了真正药物临床试验质量管理规范GCP指导原则。那时，我国肺癌学者紧跟国外潮流，按国际的临床标准做临床试验。大多临床研究都由国外学者设计方案，当时的中国只能照本宣科。在这10年当中我们和外国人学习临床试验怎么做，临床试验方案是外国学者定的，我们只是执行，只是在贡献患者，没有话语权。弄潮儿（2009-2019） 2009年，振奋人心的IPASS研究发表，这是中国肺癌学者的姓名首次登上了权威N Engl J Med。届时，我国在自身基础上参与国际大型研究设计。在肺癌领域的临床试验中，中国很多学者开始担任研究的领头人和研究委员会成员，我们参加了方案的讨论，最终的试验方案也根据我们的意见做了一些修订，包括对照组的化疗剂量等方面。虽然我们很少有机会做领头人，但是我们有话语权，可以对试验方案提出我们的意见。领潮儿（2019- ）在越来越多的研究中我们开始担任领头人。这有两个原因：一是得益于前20年我们临床医生对临床研究的理解积累、贡献和影响；第二个也是得益于中国创新药企业的发展，中国药厂做的药，临床研究中肯定会有中国人做领头人。中国胸部肿瘤临床试验转化研究长三角模式探索（2019-2059）四部曲。致敬经典，传承未来丨中国胸部肿瘤原创临床研究二十年心路历程（2007-2029）长三角肺癌团魂丨中国胸部肿瘤临床试验转化研究长三角模式探索迎难而上的亮剑精神重要历史事件——CTONG成立（2007）成立于赶潮儿阶段末期，发展于弄潮儿阶段并达到高潮。读书笔记丨感恩并传承CTONG-中国肺癌原创临床研究中国胸部肿瘤协作组（CTONG）启动会：2007年第十届全国肺癌大会踏歌而行-中国胸部肿瘤研究协作组十年发展历程（2007-2017）发布会：2017年第七届中国肿瘤学临床试验发展论坛 CTONG YOUNG成立：2023年第十三届中国肿瘤学临床试验发展论坛重要历史事件——ECLUNG成立（2019）成立于领潮儿阶段初期。长三角肺癌协作组（ECLUNG）启动会：2019年第八届西湖肺癌论坛迎难而上-长三角肺癌十年发展史（2019-2029）砥砺前行-长三角肺癌二十年发展史（2019-2039）踏歌而行-长三角肺癌三十年发展史（2019-2049）传承发展-长三角肺癌四十年发展史（2019-2059） ECLUNG YOUNG成立：2021年首届长三角肺癌博士研究论坛我们的事业：中国胸部肿瘤临床试验转化研究长三角模式探索中国胸部肿瘤临床试验转化研究长三角模式探索长三角肺癌临床试验方面有着非常深厚的历史文化底蕴，回顾历史我们发现中国临床肿瘤领域三大前辈（孙燕，廖美琳，管忠震）中，廖美琳教授是唯一一位专注肺癌的资深大咖，1970年在国内成立首个肺癌化疗专业病房，2004年作为主要研究者代表中国大陆肺癌学界参与首项国际多中心临床研究（INTEREST研究），2003年开始举办首届上海国际肺癌论坛，2012年开始举办首届中瑞国际肺癌论坛，并持续至今，影响力深远。陆舜教授在肺癌临床试验方面有着非常丰富的经验，中国首个、世界第二的肺癌第三代EGFR靶向药物阿美替尼获批上市，这是中国自主研发的第三代EGFR靶向药，打破了晚期肺癌治疗耐药后只能依赖一种进口药的困境；中国自主研发的创新1.1类新药赛沃替尼获中国国家药品监督管理局批准上市，可用于治疗MET14号外显子跳跃突变阳性的晚期非小细胞肺癌（NSCLC）患者，作为在全球范围内的首次获批，赛沃替尼不仅填补了中国此类靶向药的空白，还有望成为首个代表中国走向世界的肺癌靶向创新药物；吡咯替尼是首个由中国自主研发的新一代HER2受体抑制剂，在临床研究中疗效远超同类产品。陆舜教授和宋正波教授领衔的吡咯替尼临床研究在国际上首次证实HER2扩增晚期非小细胞肺癌（NSCLC）患者疗效显著，为扩展吡咯替尼在HER2扩增晚期非小细胞肺癌（NSCLC）的适应症做出了历史性贡献，基于以上重大成果陆舜教授荣获2021年第十五届“药明康德生命化学研究奖”。为了响应“长三角一体化发展规划”，推动肺癌规范化诊治及创新研究，2019年12月底，由上海交通大学附属胸科医院、东部战区总医院、中国科学院大学附属肿瘤医院、浙江大学医学院附属杭州市第一人民医院等40余家来自江、浙、沪、赣、皖地区的医疗机构，共同成立“长三角肺癌协作组”。成立协作组的目的，是通过设计、开展肺癌研究领域的多中心临床试验及转化研究，特殊病例多中心会诊等，为肺癌临床实践提供高级别的循证医学证据，促进长三角地区肺癌的诊疗、转化研究的创新性及前沿性，提高东部地区肺癌的诊治水平和国际影响力。长三角肺癌青年博士研究团队（长三角肺癌新生代）把中国胸部肿瘤临床试验转化研究长三角模式探索作为奋斗的事业，迎难而上作为中国胸部肿瘤临床试验转化研究长三角模式探索的方向标，长三角肺癌新生代结合时代背景特征在未来四十年时间（2019-2059）选择迎难而上，勇于向各种艰难困苦挑战和亮剑。 “爬雪山”和“过草地” 长三角肺癌与和黄药业 J Clin Oncol（NCT02590965） J Clin Oncol Randomized, double-blind, placebo-controlled, multicenter phase II study of fruquintinib after two prior chemotherapy regimens in Chinese patients with advanced nonsquamous non-small-cell lung cancer Shun Lu（2018） Lung Cancer（FALUCA） Lung Cancer A phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer-the FALUCA study Shun Lu（2020） Transl Lung Cancer Res（NCT02976116） Transl Lung Cancer Res Fruquintinib with gefitinib as first-line therapy in patients carrying EGFR mutations with advanced non-small cell lung cancer: a single-arm, phase II study Shun Lu（2021） Lancet Respir Med（NCT02897479） Lancet Respir Med Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study Shun Lu（2021） JTO Clin Res Rep（NCT02897479）JTO Clin Res Rep Long-term efficacy, safety and subgroup analysis of savolitinib in Chinese patients with non-small cell lung cancers harboring MET exon 14 skipping alterations Shun Lu（2022） Ther Adv Med Oncol（NCT02897479）Ther Adv Med Oncol Circulating tumour DNA biomarkers in savolitinib-treated patients with non-small cell lung cancer harbouring MET exon 14 skipping alterations: a post hoc analysis of a pivotal phase 2 study Shun Lu，Yong-feng Yu（2022） Lancet Respir Med（NCT04923945） Lancet Respir Med Savolitinib in patients in China with locally advanced or metastatic treatment-naive non-small-cell lung cancer harbouring MET exon 14 skipping mutations: results from a single-arm, multicohort, multicentre, open-label, phase 3b confirmatory study Shun Lu（2024）长三角肺癌与豪森药业 J Thorac Oncol（APOLLO） J Thorac Oncol Efficacy of aumolertinib (HS-10296) in patients with advanced EGFR T790M+NSCLC：updated post NMPA-approved results from the APOLLO 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non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial Shun Lu（2023） Clin Transl Oncol（ChiCTR2400087743）Clin Transl Oncol Intrapleural anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer with malignant pleural effusion: a prospective, single-arm, single-center, phase I trial Yong Song, Tang-feng Lv, Ping Zhan, Yue Hao（2025）长三角肺癌与君实生物 JAMA（Neotorch） JAMA Perioperative toripalimab plus chemotherapy for patients with resectable non-small cell lung cancer：The Neotorch randomized clinical trial Shun Lu（2024）长三角肺癌与百济神州 J Thorac Oncol（RATIONALE 304） J Thorac Oncol Tislelizumab plus chemotherapy as first-line treatment for locally advanced or metastatic nonsquamous non-small cell lung cancer (RATIONALE 304)：a randomized phase 3 trial Shun Lu（2021） JAMA Oncol（RATIONALE 307） JAMA Oncol Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer：a phase 3 randomized clinical trial Shun Lu（2021） Cancer J（RATIONALE 304） Cancer J Examining the impact of tislelizumab added to chemotherapy on health-related quality-of-life outcomes in previously untreated patients with nonsquamous non-small cell lung cancer Shun Lu（2022）长三角肺癌与海和药物 eClinicalMedicine（GLORY） eClinicalMedicine Gumarontinib in patient with non-small-cell lung cancer harbouring MET exon 14 skipping mutations：a multicentre, single-arm, open-label, phase 1b/2 trial Shun Lu, Yong-feng Yu（2023） Transl Lung Cancer Res（GLORY）Transl Lung Cancer Res Long-term follow-up results from the GLORY study: phase II study of gumarontinib in East Asian patients with MET exon 14 skipping mutated non-small cell lung cancer Shun Lu, Yong-feng Yu（2025）长三角肺癌与石药集团 Nat Commun（NCT04448379） Nat Commun Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer Zheng-bo Song，Li-yun Miao, Qian Wang, Chun-wei Xu（2023）长三角肺癌与再鼎医药 J Thorac Oncol（NCT03516084） J Thorac Oncol Efficacy and safety of niraparib as maintenance treatment in patients with extensive-stage small cell lung cancer after first-line chemotherapy：a randomized，double-blind，phase 3 study Shun Lu（2021） Lancet Respir Med（POD1UM-304）Lancet Respir Med Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study Shun Lu（2025）长三角肺癌与先声药业 J Thorac Oncol（NCT00912392） J Thorac Oncol A multicenter, open-label, randomized phase II controlled study of rh-Endostatin (endostar) in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer Shun Lu（2015） J Thorac Oncol（NCT02088515） J Thorac Oncol Nedaplatin plus docetaxel versus cisplatin plus docetaxel as first-line chemotherapy for advanced squamous cell carcinoma of the lung-a multicenter, open-label, randomized, phase III trial Shun Lu（2018）长三角肺癌与益方生物 J Thorac Oncol（NCT04585035） J Thorac Oncol D1553（garsorasib）：a potent and selective inhibitor of KRAS G12C in patients with non-small cell lung cancer：Phase I study results Shun Lu, Yi-ping Zhang, Zi-ming Li, Zheng-bo Song，Chun-wei Xu（2023） Lancet Respir Med（D1553-102）Lancet Respir Med Garsorasib in patients with KRASG¹²C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 2 trial Shun Lu，Zi-ming Li（2024） Eur J Cancer（NCT04585035 and D1553-102）Eur J Cancer Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: a pooled analysis of phase 1/2 study Shun Lu, Zheng-bo Song, Zi-ming Li, Chun-wei Xu（2025）长三角肺癌与贝达药业 J Thorac Oncol（NCT03608007） J Thorac Oncol Safety but limited efficacy of ensartinib in ROS1-positive non-small cell lung cancer: a single-arm, multicenter phase II study Shun Lu（2021） Oncologist（NCT03452150） Oncologist Phase I trial of a third generation EGFR mutant-selective inhibitor (D-0316) in patients with advanced non-small cell lung cancer Shun Lu（2022） J Thorac Oncol（IBIO-102）J Thorac Oncol Efficacy and safety of befotertinib (D-0316) in patients with EGFR T790M mutated non-small cell lung cancer that had progressed after prior EGFR TKI therapy: a phase 2, multicenter, single-arm, open-label study Shun Lu（2022） Lancet Respir Med（NCT04206072）Lancet Respir Med Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study Shun Lu（2023） Lung Cancer（IBIO-102） Lung Cancer Befotertinib for patients with pretreated EGFR T790M mutated locally advanced or metastatic NSCLC: Final overall survival results from a phase 2 trial Shun Lu（2024）长三角肺癌与恒瑞医药 J Thorac Dis（ChiCTR1800020105） J Thorac Dis Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial Yong Song（2019） Clin Cancer Res（EXPECT） Clin Cancer Res Pyrotinib in HER2-amplified advanced non-small cell lung cancer: a prospective, multicenter, single-arm trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang，Shun Lu（2022） BMC Med（EXPECT-II） BMC Med Efficacy and safety of pyrotinib in advanced lung adenocarcinoma with HER2 mutations: a multicenter, single-arm, phase II trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang，Shun Lu（2022） BMC Med（THALIA） BMC Med Apatinib in patients with recurrent or metastatic thymic epithelial tumor: a single-arm, multicenter, open-label, phase II trial Zheng-bo Song，Wen-xian Wang，Chun-wei Xu，Yi-ping Zhang（2022） Signal Transduct Target Ther（NCT04818333） Signal Transduct Target Ther SHR-A1811 (antibody-drug conjugate) in advanced HER2 mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study Shun Lu, Zi-ming Li, Zheng-bo Song（2024） Lancet Oncol（HORIZON-Lung）Lancet Oncol Trastuzumab rezetecan, a HER2-directed antibody–drug conjugate, in patients with advanced HER2-mutant non small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study Shun Lu, Zi-ming Li（2025） Cancer Cell（NCT05154604）Cancer Cell TROP2-targeted antibody-drug conjugate SHR-A1921 for advanced or metastatic solid tumors: a first-in-human phase 1 study Zheng-bo Song（2025）长三角肺癌与正大天晴药业集团 Signal Transduct Tar（NCT03019276 and NCT03972189）Signal Transduct Tar Efficacy, safety and pharmacokinetics of unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a phase I/II trial Shun Lu（2023）长三角肺癌与罗氏制药 Cancer Manag Res（NCT01297101） Cancer Manag Res Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study Shun Lu（2019） Cancer Med（IMpower132）Cancer Med Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer Shun Lu（2022）长三角肺癌与勃林格殷格翰 Onco Targets Ther（NCT01523587） Onco Targets Ther Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung Shun Lu（2018）长三角肺癌与阿斯利康 Am J Clin Oncol (RE-CHALLENGE，CTONG1304) Am J Clin Oncol Efficacy and safety of gefitinib as third-line treatment in NSCLC patients with activating EGFR mutations treated with first-line gefitinib followed by second-line chemotherapy: a single-arm, prospective, multicenter phase II study (RE-CHALLENGE, CTONG1304) Yong Song（2019） N Engl J Med（LAURA）N Engl J Med Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC Shun Lu（2024） Ann Oncol（LAURA）Ann Oncol Osimertinib after definitive chemoradiotherapy in unresectable stage III epidermal growth factor receptor-mutated non-small-cell lung cancer: analyses of central nervous system efficacy and distant progression from the phase III LAURA study Shun Lu（2024） J Thorac Oncol（PEARL） J Thorac Oncol Durvalumab versus chemotherapy as first-line treatment for metastatic NSCLC with tumor PD-L1 expression ≥25%: results from the randomized phase 3 PEARL study Shun Lu（2024）长三角肺癌与强生 N Engl J Med（MARIPOSA）N Engl J Med Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC Shun Lu（2024） N Engl J Med（MARIPOSA）N Engl J Med Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC Shun Lu（2025）长三角肺癌与武田制药 J Thorac Oncol（NCT03909971） J Thorac Oncol Lorlatinib for previously treated ALK-positive advanced non-small cell lung cancer: primary efficacy and safety from a phase 2 study in China Shun Lu（2022） Clin Lung Cancer（NCT01970865 and NCT03909971） Clin Lung Cancer Updated efficacy and safety of lorlatinib in a phase 2 study in Chinese patients with previously treated advanced ALK-positive non-small cell lung cancer Shun Lu（2024）长三角肺癌与百时美施贵宝 Lung Cancer（CheckMate-078） Lung Cancer Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer: 2-year follow-up from a randomized, open-label, phase 3 study (CheckMate 078) Shun Lu（2020） Ther Adv Med Oncol（CheckMate 870）Ther Adv Med Oncol An open label, safety study of Asian patients with advanced non-small-cell lung cancer receiving second-line nivolumab monotherapy (CheckMate 870) Shun Lu（2022）长三角肺癌与康方生物 J Thorac Oncol（NCT05116007） J Thorac Oncol Ivonescimab combined with etoposide plus carboplatin as first-line treatment for extensive-stage small-cell lung cancer: results of a phase Ib clinical trial Shun Lu（2024）长三角肺癌与礼来 Chin Med J Chin Med J Gemcitabine and cisplatin treatment over a 3-week versus a 4-week dosing schedule: a randomized trial conducted in Chinese patients with nonsmall cell lung cancer Mei-lin Liao（2008） Ther Adv Med Oncol（LIBRETTO-321）Ther Adv Med Oncol Efficacy and safety of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer: a phase II clinical trial (LIBRETTO-321) Shun Lu（2022） JCO Precis Oncol（LIBRETTO-321）JCO Precis Oncol Intracranial activity of selpercatinib in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer in the phase II LIBRETTO-321 trial Shun Lu（2023） Ther Adv Med Oncol（LIBRETTO-321）Ther Adv Med Oncol Patient-reported outcomes following selpercatinib treatment in Chinese patients with advanced RET fusion-positive non-small-cell lung cancer and thyroid cancer, and RET-mutant medullary thyroid cancer in the phase II LIBRETTO-321 trial Shun Lu（2023）长三角肺癌与齐鲁制药 J Hematol Oncol（NCT04296994 and NCT05171790） J Hematol Oncol First-in-human phase I/Ib study of QL1706(PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors Yi-ping Zhang（2023）长三角肺癌与华东医药 Cancer Commun（ChiCTR2000029058）Cancer Commun A phase II study on Mefatinib as first-line treatment of patients with advanced non-small-cell lung cancer harboring uncommon EGFR mutations Yong Song（2023）长三角肺癌与东曜药业 J Cancer Res Clin Oncol（NCT05427305）J Cancer Res Clin Oncol Bevacizumab biosimilar candidate TAB008 compared to Avastin® in patients with locally advanced, metastatic EGFR wild-type non-squamous non-small cell lung cancer: a randomized, double-blind, multicenter study Shun Lu（2023）长三角肺癌与李氏大药厂 JTO Clin Res Rep（NCT04346914）JTO Clin Res Rep Efficacy and safety of anti-programmed death-ligand 1 monoclonal antibody socazolimab with carboplatin and etoposide for extensive-stage SCLC: Results from the phase 1b clinical trial Shun Lu, Zi-ming Li（2023） Signal Transduct Target Tar（NCT04878016）Signal Transduct Target Tar A multicenter, randomized, double-blind, placebo-controlled phase 3 study of socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer Shun Lu（2025）长三角肺癌与珐博进 J Clin Oncol（NCT05301517）J Clin Oncol Efficacy and safety of roxadustat for anemia in patients receiving chemotherapy for nonmyeloid malignancies: a randomized, open-label, active-controlled phase III study Shun Lu（2024）长三角肺癌与德昇济医药 Nat Med（NCT05410145）Nat Med D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial Shun Lu, Zheng-bo Song（2025）长三角肺癌与康方生物 Lancet（HARMONi-6）Lancet Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial Shun Lu（2025）长三角肺癌与亚盛医药 EClinicalMedicine（NCT03917043）EClinicalMedicine Safety, pharmacokinetic, pharmacodynamic, and efficacy properties of orally administered APG-2449 in patients with advanced ALK+ and ROS1+ non-small-cell lung cancer: a multicentre, open-label, single-arm phase 1 trial Zheng-bo Song（2025）长三角肺癌沪浙苏赣四驱动一体化建设中国胸部肿瘤临床试验转化研究长三角模式探索临床试验-转化研究闭环式研究平台建设 1.基因多平台检测平台搭建（转化研究） 2.样本库平台搭建（转化研究） 3.罕见靶点类器官模型临床前研究平台搭建（临床试验+转化研究） 4.罕见靶点富集互联网医院平台搭建（临床试验+转化研究）心路历程心路历程1: 2019.12 长三角肺癌协作组成立心路历程2: 2020.04 长三角肺癌协作组临床试验招募启动心路历程3: 2020.07 长三角肺癌协作组青年医师巡讲团成立心路历程4: 2021.01 长三角肺癌协作组青年博士团队成立心路历程5: 2021.03 江苏省基层肺癌协作组成立心路历程6: 2021.04 长三角肺癌基因多平台检测实验室揭牌心路历程7: 2021.05 浙江省基层肺癌协作组成立心路历程8：2021.07 长三角肺癌多中心研究样本库建立心路历程9：2024.12 浙江省基层罕见肿瘤协作组成立泛长三角肺癌系列（致敬经典，传承未来）感恩并传承丨广东省人民医院吴一龙教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨香港中文大学威尔士亲王医院莫树锦教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨中山大学肿瘤防治中心张力教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨中国医学科学院肿瘤医院王洁教授团队-中国肺癌原创临床研究阶段汇总携手共赢丨吉林省肿瘤医院程颖教授团队-中国肺癌原创临床研究阶段总结成长的点滴丨解放军总医院第五医学中心刘晓晴教授团队临床试验汇总携手共赢丨湖南省肿瘤医院杨农张永昌教授团队临床试验汇总携手共赢丨河南省肿瘤医院马智勇王慧娟教授团队临床试验汇总携手共赢丨天津医科大学肿瘤医院黄鼎智教授团队临床试验汇总携手共赢丨福建省肿瘤医院黄诚林根教授团队临床试验汇总携手共赢丨山西白求恩医院张俊萍冯慧晶教授团队临床试验汇总携手共赢丨联勤保障部队第900医院余宗阳教授团队临床试验汇总整理者

2017-05-04

·BioSpace

Cytori Restarting Texas Facility it Inherited From Azaya Therapeutics Buyout Deal

May 4, 2017 By Alex Keown , BioSpace.com Breaking News Staff SAN ANTONIO, Texas – Nearly five months after acquiring Azaya Therapeutics and its nanoparticle-based oncology pipeline, Cytori Therapeutics is looking to restart production at a Texas facility and is seeking a European partner for one of the new drugs. In an interview with Xconomy , John Harris , a Cytori vice president in charge of commercial and partnership operations, said the company is looking for a European partner that has an existing pipeline that would be complemented by ATI-0918, a generic formulation of the chemotherapy drug iposomal doxorubicin. Harris said an ideal European partner will be looking for “ate-term and existing assets to put into their funnel.” As part of Cytori’s plans to push for European partnerships, the company will relaunch a Texas manufacturing site that Azaya abandoned in 2015 after the company failed to strike a deal with Hospira . While little was reported about Cytori’s plans for the San Antonio facility, Xconomy said the company is looking to have about 20 employees at the operation. Also, Cytori may add additional capabilities to that facility, such as a chemical lab. The Texas site will focus on the development of the Azaya compounds, but the facility could eventually begin to manufacture some of Cytori’s own products, Xconomy reported. In clinical trials, ATI-0918 demonstrated bioequivalence to the reference drug for doxorubicin in Europe, which is marketed by Johnson & Johnson as Doxil and Caelyx. Cytori has plans to seek European approval for its compound in 2018. Cytori is also planning to seek regulatory approval for ATI-0918 in the United States, but that will require additional studies. If the company is successful in securing U.S. authorization, ATI-0918 would have the bioequivalence of Lipodox, which is manufactured by Sun Pharma . At the time, Cytori acquired Azaya, the company said independent research showed the doxorubicin market is expected to grow to approximately $1.4 billion worldwide by 2024. Additionally, Cytori said the market has been “underserved” in recent years due to supply disruptions, which is part of the reason Cytori will ramp up production in San Antonio. Also in the acquisition, Cytori nabbed ATI-1123, a patented, nanoparticle-stabilized liposomal formulation of docetaxel. A Phase I study of that compound showed positive safety results for ATI-1123 in its Phase 1 study of 29 patients with solid tumor cancers who failed other therapies. As those products move forward, Harris told Xconomy that Cytori could license ATI-0918 on a regional basis and ATI-1123 globally. In April, Cytori received approval from the U.S. Food and Drug Administration for an Investigational Device Exemption for a pilot clinical trial to evaluate Cytori Cell Therapy in patients with thermal burn injuries. The trial will be a continuation of the company’s research under its contract with the Biomedical Advanced Research and Development Authority (BARDA) , a division of the U.S. Department of Health and Human Services .

临床1期临床结果并购

100 项与多西他赛脂质体(东曜药业) 相关的药物交易

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