PO.CT01.02 · 临床试验
First-in-Human Phase I Clinical Trials
- CT041 CT041 针对长链非编码RNA TUG1的寡核苷酸疗法治疗复发性胶质母细胞瘤的研究者发起的I期试验 Investigator-initiated phase I trial of an oligonucleotide therapeutic targeting long noncoding RNA TUG1 for recurrent glioblastoma Ryuta Saito, Fumiharu Ohka, Yohei Mineharu, Makoto Ohno, Miho Suzuki, Keiko Shinjo, Shoichi Deguichi, Yoshiki Shiba, Aya Sato, Yoshiki Arakawa, Yoshitaka Narita, Shiro Akinaga, Yutaka Kondo
- CT042 CT042 E-SYNC T细胞(一种自体抗EGFRvIII SynNotch受体诱导的抗EphA2/IL13Ra2 CAR T细胞)治疗成人EGFRvIII+胶质母细胞瘤的首次人体试验 First-in-human trial of E-SYNC T-cells, an autologous anti-EGFRvIII SynNotch receptor-induced anti-EphA2/IL13Ra2 CAR T-cells, in adult patients with EGFRvIII+ glioblastoma Payal B. Watchmaker, Jennifer L. Clarke, Ricardo Almeida, Akane Yamamichi, Abigail Hansen, Harika T. Gopi, Karishma Kumar-Wessel, Megna Reddy, David Y. Oh, Jacob S. Young, Nicholas Butowski, Nancy A. Oberheim Bush, Jennie W. Taylor, John de Groot, Joanna Phillips, Annette M. Molinaro, Brain R. Shy, Wendell Lim, Hideho Okada
-
CT043 · PDF 雄激素受体抑制以克服AR阳性转移性TNBC的紫杉烷耐药:4CAST 1b期试验的中期结果 Androgen receptor inhibition to overcome taxane resistance in AR-positive metastatic TNBC: Interim results of the 4CAST Phase 1b trial Jia Liu, Rasha Cosman, Sarah Childs, Jordan E. Cohen, Anthony Rodrigues, Thomas Hansen, Belinda E. Kiely, Julia Chen, Anuradha Pala, Geeta Sandhu, Juliet Ho, Sandunika Warakulasuriya, Doha Elgundi, Hao-Wen Sim, Robert Kent, Chloe Martin, Elizabeth M. Woodson, Christine L. Chaffer, Rachel Dear
-
CT044 · PDF 一项研究者发起的1B期试验:niraparib导入治疗,随后niraparib联合dostarlimab用于转移性BRCA1/2突变型乳腺癌、输卵管-卵巢癌及胰腺癌 A phase 1B investigator-initiated trial of niraparib lead-in, followed by niraparib plus dostarlimab for metastatic BRCA1/2 -mutated breast, tubo-ovarian, and pancreatic cancers Elizabeth M. Swisher, Andrew Coveler, Kalyan Banda, Lynn Symonds, Isabel Rodriguez, Hannah H. Lee, Reina Hibbert, Jeniece Hensel, Harini Ramachandran, Tiffany N. Jones, Kelsey Baker, Mary Redman, Jennifer Specht
-
CT045 · PDF START-002的初步临床和转化研究结果及推荐2期剂量(RP2D)的选择:一项invikafusp alfa(一种首创双T细胞激动剂)联合sacituzumab govitecan治疗转移性三阴性或HR+/HER2-乳腺癌的1b/2期研究 Initial clinical and translational results and selection of recommended phase 2 dose (RP2D) from START-002: A Phase 1b/2 study of invikafusp alfa, a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in metastatic triple-negative or HR+/HER2- breast cancer Steven J Isakoff, Anastasia Martynova, Philippe L Bedard, Margaret E Gatti-Mays, Nathalie LeVasseur, Andreas Varkaris, William Randolph, Karunya Srinivasan, Shannon McCue, Zhenming Shun, Ke Liu, Zhen Su, Kevin Chin, Virginia Kaklamani, Kelly McCann, Erika Hamilton
-
CT046 · PDF 一种首创的HER2靶向放射性药物疗法:177Lu-RAD202治疗HER2+晚期实体瘤的0/1期HEAT试验的初步结果 A first-in-class HER2-targeted radiopharmaceutical therapy: Initial findings from the Phase 0/1 HEAT trial of 177Lu-RAD202 in HER2+ advanced solid tumors Aviral Singh, Udit Nindra, Ian Swainson, Dimitris Voliotis, Veronica Wong
-
CT047 · PDF 在一项1期临床试验中,Maackia amurensis种子凝集素(MASL)对OSCC细胞形态、PDPN表达、活力和运动性的影响 Effects of Maackia amurensis seed lectin (MASL) on OSCC cell morphology, PDPN expression, viability, and motility in a phase 1 clinical trial Ariel C. Yin, Cayla J. Holdcraft, Tyler J. Hellmig, Eamonn J. Brace, David I. Suster, Alan J. Shienbaum, Dylan Roden, Evelyne Kalyousef, Ghayoour Mir, Eugenio Capitle, Soly Baredes, Rabie Shanti, Mika K. Kaneko, Yukinari Kato, Hisataka Kobayashi, Aki Furusawa, Mahnaz Fatahzadeh, Gary S. Goldberg
-
CT048 · PDF IMT-009(IMT)在晚期癌症中的首次人体剂量递增(DE)和生物标志物队列扩展(BCE),以及IMT与fruquintinib(F)联合治疗微卫星稳定型结直肠癌(MSS CRC)的1b期(Ph1b)研究 A first in human, dose escalation (DE) and biomarker cohort expansion (BCE) of IMT-009 (IMT) in advanced cancer and Phase 1b (Ph1b) combination with fruquintinib (F) in microsatellite stable colorectal cancer (MSS CRC) Susanna V. Ulahannan, Melissa Johnson, Jason T. Henry, Shruti Malu, Sudhir Manda, Manish R. Patel, Shivaani Kummar, Adwitiya Kar, Alexander Spira, Vivian Cline, Ana L. Costa, Sarah Djeddi, Diane Stebbins, Nicholas Ferenc, Lucy Chen, James E. Wooldridge, Cesar A. Perez
-
CT050 · PDF TAVO412(一种抗EGFR/cMET/VEGF多特异性抗体)治疗晚期或转移性实体瘤患者的初步临床结果 Preliminary clinical results of TAVO412, an anti-EGFR/cMET/VEGF multispecific antibody, in patients with advanced or metastatic solid tumors Mark Chiu, Yanjiao Yu, Mira Zhao, Wei Zhang, Hong Xie, Chao Han
-
CT051 · PDF 从临床前模型到STC-1010免疫疗法治疗不可切除晚期结直肠癌的首次人体评价 From preclinical models to first-in-human evaluation of STC-1010 immunotherapy in unresectable advanced colorectal cancer Diego Tosi, Antoine Italiano, Antoine Hollebecque, Benoît You, Philippe Cassier, Francesco Sclafani, David Tougeron, Eric Christenson, Céline Gongora, Iseulys Richert, George Alzeeb, Paul Marteau, Marion Brun, Leila Feki, Lionel Chalus, Benoit Pinteur, Paul Bravetti, Sarah Kerbouche, Corinne Tortorelli, François Ghiringhelli
-
CT052 · PDF 一项1期单次递增剂量(SAD)研究的机制验证:评价LRK-4189在健康受试者中的安全性、耐受性、药代动力学和药效学 Proof of mechanism from a phase 1, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of LRK-4189 in healthy subjects Krista Goodman, Eva d'Hennezel, Morgan O'Shea, Melvyn Chow, Julie Arnold, Sujen Lai, Catherine Sabatos-Peyton, Amber Morgan, Phillipa Graham, Alice Bexon, Sharan Sidhu, Eric Van Cutsem
-
CT053 · PDF CT-01(一种GSPT1和NEK7双重降解剂)单药或联合依维莫司(everolimus)治疗肝细胞癌的1期临床试验 A phase 1 clinical trial of CT-01, a dual degrader of GSPT1 and NEK7, alone or in combination with everolimus for the treatment of hepatocellular carcinoma Anna Maria Serwotka-Suszczak, Andrew Saunders, Krzysztofa Odrzywol, Robert Dyjas, Piotr Kowalczyk, Przemysław Glaza, Roman Pluta, Karolina Brodzik, Joanna Lis, Olga Makowska, Joanna Majkut, Martyna Mianowska, Paulina Rozborska, Anna Sawicka, Marta Sowała, Agata Śnieżewska, Katarzyna Kaczanowska, Jan Klajn, Grzegorz Statkiewicz, Arkadiusz Zając, Katarzyna Brach, Michał Biśta, Paweł Dobrzański, Sylvain Cottens, Michał Walczak
-
CT054 · PDF 1b/2期Morpheus肝癌研究在不可切除的局部晚期或转移性肝细胞癌(HCC)患者中的结果:Muzastotug(ADG126:掩蔽型抗CTLA-4抗体)联合治疗组 Results from the phase 1b/2 Morpheus liver study in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC): Muzastotug (ADG126: masked anti-CTLA-4 Ab) combination arm Daneng Li, Edward Gane, Chih-Hung Hsu, Adam Burgoyne, Peter Luo, Songmao Zheng, Yan Li, Xiaohong She, Stanley Frankel, Jiping Zha, Ann-Lii Cheng
-
CT055 · PDF AU409(一种同类首创的转录调节剂)在晚期实体瘤和肝细胞癌中的早期临床活性及肿瘤转录调控:两项I期研究的结果 Early clinical activity and tumor transcriptional modulation of AU409, a first-in-class transcription regulator, in advanced solid tumors and hepatocellular carcinoma: Results from two phase I studies Anthony El-Khoueiry, Anastasia Martynova, Diana Hanna, Jacob Thomas, Syma Iqbal, Sandra Algaze, Viwat Visuthikraisee, Brenton Louie, Gregory Luedtke, Xiaoyi Li, Pek Lum, Chi Leung Chiang
-
CT056 · PDF 瘤内微器械的I期研究揭示头颈部腺样囊性癌中不同药物处理区域间异质性的免疫和凋亡反应 Phase I study of intratumoral microdevices reveals heterogenous immune and apoptotic responses across distinct drug-treated regions in adenoid cystic carcinoma of the head and neck Fanni Santa, Joseph Kotler, Simon Chow, Sharath K. Bhagavatula, Vickie Y. Jo, Hannah Roth, Vincenzo Tarallo, Samantha E. Martin, Ellen Maloney, Wooseok Ahn, Glenn J. Hanna, Oliver Jonas
-
CT057 · PDF MK-2010(一种PD-1×VEGF双特异性抗体)首次人体研究的初步结果 Preliminary results from the first-in-human study of MK-2010, a PD-1×VEGF bispecific antibody Jin Li, Weizheng Kou, Longhua Sun, Yanqiu Zhao, Rusen Zhao, Baozhong Wang, Shaozhang Zhou, Juan Li, Xuewen Liu, Jun Zhao, Dongqing Lv, Gaofeng Li, Junli Xue, Yong Fang, Daren Lin, Jianhua Shi, Yi Gong, Xia Qin, Yi Zuo, Erik H. Knelson, Weijuan Zhang, Caicun Zhou
-
CT060 · PDF D3S-002(一种专门设计的ERK1/2抑制剂)在伴MAPK通路突变的晚期实体瘤中的首次人体1期研究 First in human phase 1 study of D3S-002, a purposely designed ERK1/2 inhibitor, in advanced solid tumors with MAPK pathway mutations Yi-Long Wu, Michael Millward, Yanqiao Zhang, Matteo S. Carlino, Xian Wang, Amitesh Roy, Jun Zhang, Jun Zhao, Zhen Wang, Amy Weise, Debora Doroshow, Shaonan Wang, Zifei Fan, Rong Su, Jing Zhang, Jia Wang, Wenqian Wang, Cheng Chen, Qian Chen, Hui Wang, Zhijian Chen
-
CT061 · PDF II型ROS1 TRK抑制剂ANS03在ROS1融合阳性肺癌中的I期研究 A phase I study of the type II ROS1 TRK inhibitor ANS03 in ROS1 fusion-positive lung cancers Alexander Drilon, Jia Yu, Zhiyong He, Yongsheng Wang, Kejing Tang, Tianqing Chu, Shutan Liao, Junjun Zhang, Xinlong Zheng, Jaime Rubio-Perez, Matteo Repetto, Brendan Putz, Shengxiang Ren
-
CT062 · PDF IK-595(一种新型MEK-RAF分子胶)1期扩展研究在NRAS/KRAS突变晚期肿瘤患者中的单机构经验 Single institution experience of the phase 1 expansion study of IK-595, a novel MEK-RAF molecular glue, in patients with NRAS/KRAS mutated advanced tumors Jennifer Brooke Valerin, April Choi, Connie Kang, Miranda Duron, Christine Choe, Katherine Kim, Trupti Lingaraj, David Damphousse, Farshid Dayyani
-
CT063 · PDF 靶向EphA2的Bicycle药物偶联物(BDC)BT5528联合nivolumab治疗晚期实体瘤患者(pts):一项1/2期研究结果 An EphA2-targeting Bicycle Drug Conjugate (BDC), BT5528, in combination with nivolumab in patients (pts) with advanced solid tumors: Results from a Phase 1/2 study Babar Bashir, Juan Martin-Liberal, Judy S. Wang, Raid Aljumaily, Bernard Doger de Spéville, Elena Garralda, Meredith McKean, Elisa Fontana, Hans Prenen, Daniel A. Peterson, Vienna Reichert, Xuemin Gu, Mengyao Li, Assunta De Rienzo, Alastair Greystoke
-
CT064 · PDF ACE-106(一种高选择性、潜在同类最优的PARP1抑制剂)治疗晚期实体瘤的首次人体1/2期研究更新结果 Updated results from a first-in-human phase 1,2 study of ACE-106, a highly selective and potentially best-in-class PARP1 inhibitor in advanced solid tumors Xingyun Cai, Jian Zhang, Yu Chen, Yanxia Shi, Wei Wang, Zhanhong Chen, Jiongjie Chen
-
CT065 · PDF SGR-3515(一种Wee1/Myt1双重抑制剂)在晚期实体瘤受试者中一项正在进行的1期研究(SGR-3515-101)的初步安全性、药代动力学和药效学 Preliminary safety, pharmacokinetics and pharmacodynamics of SGR-3515, a Wee1/Myt1 dual inhibitor from an ongoing Phase 1 study in participants with advanced solid tumors (SGR-3515-101) Stephanie Lheureux, Michael K. Gibson, Kathleen N. Moore, Wendel Naumann, Mohamad Salkeni, Pedro Hermida de Viveiros, Deborah Doroshow, David Miller, Vivek Subbiah, Ira Winer, Shaoxian Sun, Peter Skrdla, Francois Lafleur, Steven Pirie-Shepherd, Sarsvat Patel, Yi Zhang, Kevin Wu, Margaret Dugan, Patricia M. LoRusso
-
CT066 · PDF 靶向热疗诱导免疫原性肿瘤重塑并在免疫治疗难治性转移性黑色素瘤中显示早期临床缓解 Targeted hyperthermia induces immunogenic tumor remodeling and demonstrates early clinical response in immunotherapy-refractory metastatic melanoma Barry Kennedy, Carman Giacomantonio, Kate Clark, Julie Jordan, Cheryl Dean, Nick Cheverie, Kelly Corscadden, Caitlin Gormley, Geetha Subramanian, Erin Noftall, Alexander Roth