Phase I Clinical Trials in Progress

• CT070 · PDF 自体GD2-CAR-T细胞治疗复发性GD2阳性胶质母细胞瘤患者一项正在进行的剂量递增研究的初步临床和实验室结果 Initial clinical and laboratory results of an ongoing dose escalation study of autologous GD2-CAR-T cells in patients with recurrent GD2-positive glioblastoma Michael P. Brown, Abbey Le Blanc, Sidra Khan, Sandy Patel, Jesikah Logan, Olivia Franze, Erica C. F. Yeo, Nga T. H. Truong, Tessa Gargett
• CT071 · PDF 抗P-selectin抗体crizanlizumab治疗新诊断非甲基化胶质母细胞瘤的I/II期研究 Phase I/II study of the anti-P-selectin antibody crizanlizumab for newly-diagnosed unmethylated glioblastoma Anne Krinsky, Anshika Katyal, Opal Avramoff, Yulia Liubomirski, Ranit Aharonov, Tuvik Beker, Gal Dinstag, Omer Tirosh, Alisa Talianski, Ronnie Frommer-Shapira, Ronit Satchi-Fainaro
• CT072 · PDF 新型靶向微环境以降低高危TNBC的转移复发：四硫钼酸盐（TM）联合卡培他滨治疗高复发风险乳腺癌患者的随机II期研究 Novel targeting of the microenvironment to decrease metastatic recurrence of high-risk TNBC: A randomized phase II study of tetrathiomolybdate (TM) plus capecitabine in patients with breast cancer at high risk of recurrence Linda T. Vahdat, Nancy Chan, Ben H. Park, Jessica M. Sharpe, Kathy D. Miller, Bryan P. Schneider, Kevin M. Kalinsky, Neelima Vidula, Mark E. Robson, Peter A. Kauffman, Rebecca A. Shatsky, Joyce A. O'Shaughnessy, Sujata Patil, Eileen H. Shinn, James Talton, Raven M. Lavoie, Naomi T. Kornhauser, Christina A. Seymour, Rebecca E. Dabrowski, Vivek Mittal
• CT073 · PDF FiREBOLT：一项评估LY4337713放射性配体治疗在特定FAP+实体瘤成人患者中的1期研究（研究进行中） FiREBOLT: A phase 1 study evaluating radioligand therapy with LY4337713 in adults with select FAP+ solid tumors (Trial in progress) Gary A. Ulaner, Shadi Esfahani, Joyce O'Shaughnessy, Andrei Iagaru, Dejan Juric, Vikas Prasad, Anthony F. Shields, Aman Opneja, Arthur J.A.T Braat, Wolfgang P. Fendler, Jian Liu, Richard Cioci, Issraa Shoucair, Frankis Almaguel
• CT074 · PDF CAN2109（一种新型、长效、肿瘤滞留型免疫原性细胞死亡诱导剂）的1期研究 A phase 1 study of CAN2109, a novel,long-acting, tumor-retained, immunogenic cell death inducer Herui Yao, Ning Li, Henry Ninghui Yu, Giorgio Massimini, Jianli Zhao, Shuhang Wang, Yiming Zhao, Yue Yu, Xiuping Lai, Xiaozhi Lv, Shaoshan Wang, Xia Guo, Jiancheng Huang, Fei Tan, Erwei Song
• CT075 CT075 CTPS2表达缺失暴露出对选择性CTPS1抑制的合成致死易感性：dencatistat（STP938）的1期剂量爬坡研究及在生物标志物筛选队列中的安全性扩展 Lack of CTPS2 expression exposes synthetic lethal vulnerability to selective CTPS1 inhibition: A phase 1 dose escalation study of dencatistat (STP938) with safety expansion in biomarker selected cohorts Donna M. Graham, David Sommerhalder, Douglas Orr, Rowan Miller, Neeharika Makani, David O'Malley, Ira Winer, Philip A. Beer, Karen Smith, Maureen Higgins, John R. Hawse, Xiyin Wang, Saravut J. Weroha, Christophe Massard, Patricia Roxburgh
• CT077 · PDF STRO-004 ST1：一项评估STRO-004在难治/复发转移性实体瘤成人患者中安全性、药代动力学及初步抗肿瘤活性的1期开放标签研究 STRO-004 ST1: Phase 1 open-label study to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 in adults with refractory/recurrent metastatic solid tumors David Sommerhalder, Joshua Reuss, Leontios Pappas, Mohamad A. Salkeni, Andrae Vandross, Jason T. Henry, Genevive Hernandez, Milan Mangeshkar, Jennifer Oliver, Manish R. Patel
• CT078 · PDF UCL70802（一种LACO-Stim装甲型抗CD70 CART细胞疗法）在转移性透明细胞肾细胞癌（mccRCC）患者中的首次人体1期研究 First-in-human phase I study of UCL70802, a LACO-Stim armored Anti-CD70 CART cell therapy, in patients with metastatic clear cell renal cell carcinoma (mccRCC) Xinxin Gan, Wei Li, Wei Zhang, Jiean Ding, Jiatao Hu, Changshun Wu, Lingling Lu, Cong Han, Xiaojun Liu, Yangbing Zhao, Linhui Wang
• CT079 · PDF EIU-104101：EVOLVE104（一种三特异性CD3×CD2×ULBP2/5/6 T细胞衔接器）在晚期尿路上皮癌和鳞状细胞癌中的首次人体1a/1b期研究 EIU-104101: A first-in-human phase 1a/1b study of EVOLVE104, a trispecific CD3×CD2×ULBP2/5/6 T cell engager, in advanced urothelial and squamous cell carcinomas Manish Sharma, Alex Spira, Meredith McKean, Jacqueline Brown, Thomas Marron, Stella Martomo, Xiaowei Guan, Astha Bhatia, Shaun O'Brien, Oksana Sergeeva, Keri Urwin, Jay Fine, Anthony S. Fiorino
• CT080 · PDF 一项开放标签、Ib期剂量扩展研究，评估CD137/FAP激动剂BI 765179联合pembrolizumab作为一线治疗在转移性或不可治愈、复发性PD-L1阳性头颈部鳞状细胞癌中的疗效 Open-label, Phase Ib dose-expansion study assessing the efficacy of the CD137/FAP agonist BI 765179 plus pembrolizumab as first-line therapy in metastatic or incurable, recurrent PD-L1-positive head and neck squamous cell carcinoma Rachna T. Shroff, Dejan Radonjic, Jianrui Hou, Marta Puig, Jean-Pascal Machiels
• CT081 · PDF 通过压力增强药物递送（PEDD）新辅助区域递送TLR9激动剂Nelitolimod治疗可切除微卫星稳定型结直肠癌肝转移的首次人体研究 First-in-human study of neoadjuvant regional delivery of the TLR9 agonist Nelitolimod via pressure enabled drug delivery (PEDD) in resectable microsatellite stable colorectal liver metastases Nicholas J. Hornstein, Axel Grothey, Richard Carvajal, Codruta Chiuzan, Craig Devoe, Anna Levy, Gerardo Vitiello, David Tuveson, Danielle Deperalta, Matthew Weiss, Arvind Rishi, Igor Lobko, Jonathan Weinstein, Semir Beyaz, Peter Westcott, Sepideh Gholami
• CT082 · PDF 一项toripalimab联合nadunolimab治疗化疗难治性转移性微卫星稳定型（MSS）结直肠癌（CRC）的1b/2期研究 A phase 1b/2 study of toripalimab and nadunolimab for the treatment of chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer (CRC) Jacob Alexander Lowy, Jesse Boumelha, Manik Uppal, Fionnuala Crowley, Matthew D. Park, Natalie Lucas, Kathy H. Wu, Jessica Wilk, Jordan Cuevas, Joseph Watters, Lisa Fitzgerald, Marvin Gordon, Gabriela Fazilov, Zay Yar Myint, Christina Noel, Clotilde Hennequin, Jessica Le Berichel, Seungjun Ahn, Deborah B. Doroshow, Dmitriy Zamarin, Miriam Merad, Thomas Marron, Dan Feng
• CT083 · PDF ADG126（muzastotug，一种抗CTLA-4遮蔽抗体）联合pembrolizumab（Pembro）的IO双药方案再联合fruquintinib（Fruq）治疗晚期和转移性微卫星稳定型结直肠癌的Ph1b期评估 Ph1b evaluation of ADG126 (muzastotug, an anti-CTLA-4 masking antibody) pembrolizumab (Pembro) IO doublet in combination with fruquintinib (Fruq) in advanced and metastatic microsatellite stable colorectal cancer Marwan Fakih, Sunil Sharma, Manish R. Patel, Daneng Li, Yan Li, Luke Chung, Songmao Zheng, Xiaohong She, Stanley Frankel, Michael J. Chisamore, Peter Luo, Jiping Zha
• CT084 · PDF 一项评估BXQ-350联合mFOLFOX7和贝伐珠单抗治疗新诊断转移性结直肠癌患者（mCRC）疗效和安全性的Ib/2a期研究：CIPN事件发生率和严重程度较低的证据 A Phase 1b/2a study to evaluate the efficacy and safety of BXQ-350 in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma patients (mCRC): Evidence of lower incidence and severity of CIPN events Reema Patel, Daniel Flora, Ari Baron, Davendra Sohal, Saima Sharif, Julie Anne gemmill, Fa Chyi Lee, Gilles H. Tapolsky, Michael Gazda, James Beach, Tariq Arshad
• CT085 · PDF 吉西他滨、顺铂、白蛋白结合型紫杉醇和替雷利珠单抗（GENTIS）治疗晚期胆道癌患者的Ib/2期试验 A phase 1b/2 trial of gemcitabine, cisplatin, nab-paclitaxel, and tislelizumab (GENTIS) in patients with advanced biliary tract cancer Hong Jae Chon, Ilhwan Kim, Jin Won Kim, Minsu Kang, Myung-Ah Lee, Hye Jin Choi, Choong-kun Lee, Woo Kyun Bae, Jung Yong Hong, Seonjeong Woo, Ho Yeong Lim, Beodeul Kang, Jung Sun Kim, Chan Kim
• CT086 · PDF 一项靶向CDH17的ADC（DB-1324）治疗晚期/转移性胃肠道肿瘤参与者的1/2期首次人体研究 A phase 1/2, first-in-human study of an ADC targeting CDH17 (DB-1324) in participants with advanced/metastatic gastrointestinal tumor Lin Shen, Jifang Gong, Jermaine Coward, Rajiv Shinde, Joe Wei, Yanhong Deng, Yanqiao Zhang, Ming Lu, Meili Sun, Sreenivasa Chandana, Davendra Sohal, Ting Zhang, Hua Mu, Yuran Liang, Haiqing Hua, Xiaodong Sun, Yang Qiu, Jiajia Chen, Zhongyuan Zhu
• CT087 · PDF IPN60300（一种靶向ITGA2的首创ADC）的I/II期FIH研究，评估其在局部晚期实体瘤成人患者中的安全性、耐受性、PK、生物标志物、免疫原性和抗肿瘤活性 Phase I/II FIH study of IPN60300, a first-in-class ADC targeting ITGA2, to assess the safety, tolerability, PK, biomarkers, immunogenicity and antitumor activity in adults with locally advanced solid tumors Manish R. Sharma, Jiyan Zou, Benjamin Beaufils, Aurelie Courtin, Sophie Colombo, Lineu Domit, Xiaofeng Shi, Elisabetta Leo, Shubham Pant
• CT088 · PDF [212Pb]VMT-a-NET治疗晚期SSTR2+神经内分泌肿瘤：来自剂量探索队列1、2和3的安全性和初步疗效结果 [ 212 Pb]VMT-a-NET in advanced SSTR2+ neuroendocrine tumors: safety and preliminary efficacy results from dose-finding cohorts 1,2 and 3 Thorvardur R. Halfdanarson, Richard L. Wahl, Vineeth Sukrithan, Brandon R. Mancini, Seyed A. Mosallaie, Savitha Balaraman, Gregory S. Sibley, Jason Starr, Lowell B. Anthony, Chih Y. Liao, Samuel H. Mehr, Jared Weiss, Robert A. Ramirez, Lucia Baratto, Wenjing Yang, Alaa Hanna, Stephen M. Keefe, Markus Puhlmann, Vikas Prasad
• CT089 · PDF 不可逆电穿孔（IRE）联合瘤内CD40抗体增强局部晚期胰腺癌中T细胞对个性化新抗原的反应性 Irreversible electroporation (IRE) with intratumoral CD40 antibody increases T-cell reactivity to personalized neoantigens in locally advanced pancreatic cancer Spencer Mirabile-Brightman, Bjoern Peters, Himangshu Sonowal, Zachary Berman, Zev Wainberg, Aaron Miller, Karen Messer, Jiayu Chen, Yago Pico de Coana, Peter Ellmark, Stephen Schoenberger, Rebekah R. White
• CT090 · PDF 一项可植入微器件用于胰腺癌患者原位评估药物反应的初步研究 Pilot study of an implantable microdevice for in situ evaluation of drug response in patients with pancreatic cancer Oliver Standring, Julien Hohenleithner, Daniel King, Oliver Jonas, Sepideh Gholami, Danielle DePeralta, Arvind Rishi, David Tuveson, Matthew Weiss
• CT091 · PDF 进行中的试验：个体化新抗原疫苗联合PD-1阻断与CD40激动在已切除胰腺导管腺癌中的I期研究 Trial in progress: A phase I study of personalized neoantigen vaccination combined with PD-1 blockade and CD40 agonism in resected pancreatic ductal adenocarcinoma S. Daniel Haldar, Jason Willis, Arjun Katailiha, Amjad Talukder, Brandon Smaglo, Nicole Balmaceda, Camila Braganca Xavier, Dan Zhao, M. Pia Morelli, Ryan Huey, Chandrikha Chandrasekharan, Florencia McAllister, Shubham Pant, Jane Thomas, Anirban Maitra, Scott Kopetz, Greg Lizee, Michael J. Overman
• CT092 · PDF 一项靶向ADAM9的ADC（DB-1317）用于特定晚期或转移性实体瘤受试者的1a/1b期首次人体研究 A Phase 1a/1b, first-in-human study of an ADC targeting ADAM9 (DB-1317) in participants with selected advanced or metastatic solid tumors Charlotte Lemech, Alexander Spira, David Sommerhalder, Siqing Fu, Feijiao Ge, Hua Mu, Yang Yang, Yang Qiu, Jiajia Chen, Rong Shi, Zhongyuan Zhu, Ruihua Xu
• CT093 · PDF DOC1021树突状细胞疗法在可切除或临界可切除胰腺癌中的临床与免疫学评估 Clinical and immunologic assessment of DOC1021 dendritic cell therapy in resectable or borderline resectable pancreatic cancer Vanaja Konduri, Akshar Trivedi, Wei Liu, Madhuri Namekar, Keenan Ernste, Glenn G. Wilson, Elizabeth Duus, Tannaz Armaghany, Shalini U. Makawita, E. Ramsay Camp, George Van Buren, Laura K. Aguilar, Benjamin L. Musher, William K. Decker
• CT094 · PDF BDC-4182（一种靶向claudin18.2的新一代免疫刺激抗体偶联物[ISAC]）在晚期胃癌和胃食管癌患者中的1/2期研究 A Phase 1/2 study of BDC-4182, a claudin18.2-targeting next generation immune-stimulating antibody conjugate (ISAC), in patients with advanced gastric and gastroesophageal cancer Sophia Frentzas, Michelle Morris, Megan Barnet, Niall Tebbutt, Mark Wong, Michael Michael, Hyung-Don Kim, Keun-Wook Lee, Sun Young Rha, Sang Cheul Oh, I-Chen Wu, Li-Yuan Bai, Wen-Chi Chou, Ming-Huang Chen, Yen-Yang Chen, Chia-Chi Lin, Anthony Rodrigues, Jason Ptacek, Michael N. Alonso, Tariq Arshad, Jakob Dupont, Kristi Balacy, Sung Hee Lim
• CT095 · PDF CVL006联合治疗在晚期实体瘤中的I/II期临床试验 Phase I/II clinical trial of CVL006 combination therapy in advanced solid tumors Steve Shen, Li Zhang, Wenfeng Fang
• CT096 · PDF 一种瘤内AAV2-RUNX3基因疗法（RX001）用于晚期KRAS突变NSCLC的首次人体研究（NCT06934590）：进行中的1期试验 A first-in-human, intra-tumoral AAV2- RUNX3 gene therapy (RX001) for advanced KRAS-mutant NSCLC (NCT06934590): Phase 1 trial in progress Hee Joung Kim, Sung Yong Lee, Jung Seop Eom, Dongil Park, Kyoungmi Jung, You-Soub Lee, Hongseok Ji, Suk-Chul Bae, Kye Young Lee
• CT097 · PDF 一项SMARCA2降解剂PLX-61639在SMARCA4突变的局部晚期或转移性实体瘤患者中的1期首次人体研究 A Phase 1, first-in-human study of the SMARCA2 degrader, PLX-61639, in patients with SMARCA4-mutated, locally advanced or metastatic solid tumors Jorge F. DiMartino, Alexander Spira, Anjali Rohatgi, Muhammad R. Khawaja, Laura Alder, Ibaiyi Dagogo-Jack, Miguel A. Villalona, Drew Rasco, Adam Rock, Afshin Dowlati, Robin Guo
• CT099 · PDF 一项1/2a期开放标签临床试验，评估VBC101（一种EGFR和cMET靶向双特异性抗体药物偶联物[ADC]）在晚期实体瘤恶性肿瘤受试者中的疗效 Phase 1/2a open-label clinical trial evaluating VBC101, an EGFR and cMET targeted bi-specific antibody drug conjugate (ADC), in participants with advanced solid tumormalignancies Nehal Lakhani, David Sommerhalder, William McKean, Alexander Spira, Lei Chen, Ying Li, Wei Wang, Wei Gu, Jing Li, Shun Lu

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