Phase I Clinical Trials in Progress

• CT070 · PDF 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 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 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: 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 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 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: 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 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: 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 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 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 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 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 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 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 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 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 [ 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 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 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 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 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 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 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 Phase I/II clinical trial of CVL006 combination therapy in advanced solid tumors Steve Shen, Li Zhang, Wenfeng Fang
• CT096 · PDF 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 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 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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