Combining a WT1 Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1–Expressing Diffuse Pleural Mesothelioma: A Phase 1 Study by Prashasti Agrawal, MD, Michael Offin, MD, Victoria Lai, MD, Michelle S. Ginsberg, MD, Prasad S. Adusumilli, MD, FACS, Valerie W. Rusch, MD, Jennifer L. Sauter, MD, Teresa Ho, BS, Phillip Wong, PhD, Marjorie G. Zauderer, MD

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A Bayesian tool for optimizing sample size in phase I dose-finding trials for head and neck cancer by Sivakamavalli Jeyachandran

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Exploring Serum Ceruloplasmin Dynamics in Stage II Periodontitis: Pre- and PostPhase I Therapy Assessment by P. T Priyangha, Jaishree Tukaram Kshirsagar, D Kalaiselvan

Subjects: “…phase i therapy…”
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Safety, Tolerability and Pharmacokinetics of Intravenous Sodium Taurodeoxycholate, HY209, a GPCR19 Agonist Inhibiting Inflammasomal Activation by Chung WK, Jeon I, Jang IJ, Seong SY, Han SA, Yu KS

Subjects: “…phase i clinical trial…”
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Neoantigen DNA vaccines are safe, feasible, and induce neoantigen-specific immune responses in triple-negative breast cancer patients by Xiuli Zhang, S. Peter Goedegebuure, Michael Y. Chen, Rashmi Mishra, Felicia Zhang, Yik Yeung Yu, Kartik Singhal, Lijin Li, Feng Gao, Nancy B. Myers, Tammi Vickery, Jasreet Hundal, Michael D. McLellan, Mark A. Sturmoski, Samuel W. Kim, Ina Chen, Jesse T. Davidson, Narendra V. Sankpal, Stephanie Myles, Rama Suresh, Cynthia X. Ma, Ademuyiwa Foluso, Andrea Wang-Gillam, Sherri Davies, Ian S. Hagemann, Elaine R. Mardis, Obi Griffith, Malachi Griffith, Christopher A. Miller, Ted H. Hansen, Timothy P. Fleming, Robert D. Schreiber, William E. Gillanders

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Determining doses for backfill cohorts based on patient-reported outcome by Xin Chen, Jingyi Zhang, Bosheng Li, Fangrong Yan

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Afatinib and Necitumumab in EGFR-Mutant NSCLC with Acquired Resistance to Tyrosine Kinase Inhibitors by Nathaniel J. Myall, MD, Jennifer G. Whisenant, PhD, Joel W. Neal, MD, PhD, Wade T. Iams, MD, Karen L. Reckamp, MD, Sally York, MD, PhD, Lynne D. Berry, PhD, Yu Shyr, PhD, Leora Horn, MD, Heather A. Wakelee, MD, Sukhmani K. Padda, MD

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Ethical reflections on phase I clinical trials of anticancer drugs: from a Chinese IRB’s empirical perspective by Xiaoling Liu, Zhengbo Song, Shuting Tang, Zhaochen Wang, Ji Zhu

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Feasibility of enzalutamide on patients with recurrent non-muscle-invasive bladder cancer with marker tumors: phase I study by Takashi Kawahara, Shuya Kandori, Takahiro Kojima, Bryan J. Mathis, Masanobu Shiga, Hiroyuki Nishiyama

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Adoptive cell therapy with tumor-infiltrating lymphocytes in combination with nivolumab in patients with advanced melanoma by D. König, B. Kasenda, M. Sandholzer, A. Chirindel, A. Zingg, R. Ritschard, H. Thut, K. Glatz, E.A. Kappos, D. Schaefer, C. Kettelhack, J. Passweg, K. Baur, A. Holbro, A. Buser, D. Lardinois, L.T. Jeker, N. Khanna, F. Stenner, M.S. Matter, N. Rodrigues Mantuano, M. Binder, A. Zippelius, H. Läubli

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Safety, Tolerability, and Pharmacokinetics of NIM‐1324 an Oral LANCL2 Agonist in a Randomized, Double‐Blind, Placebo‐Controlled Phase I Clinical Trial by Andrew Leber, Raquel Hontecillas, Nuria Tubau‐Juni, Josep Bassaganya‐Riera

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A phase I study using bortezomib (Velcade), cladribine, and rituximab in treating patients over 50 years old with mantle cell lymphoma by Jeffrey J. Pu, Jeffrey J. Pu, Kristin N. Berger, Chunlei Zheng, Chunlei Zheng, Nhan Do, Nhan Do, David F. Claxton, W. Christopher Ehmann, Joseph J. Drabick, Haiquan Li, Thomas P. Loughran, Elliot M. Epner

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A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in... by Thomas R. Moench, Lakshmi Botta, Brian Farrer, Jason D. Lickliter, Hyunah Kang, Yoona Park, Cheolmin Kim, Marshall Hoke, Miles Brennan, Morgan D. McSweeney, Zachary Richardson, John B. Whelan, Jong Moon Cho, Soo Young Lee, Frances Faurot, Jeff Hutchins, Samuel K. Lai

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Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label,... by Junya Furukawa, Yasumasa Kakei, Sae Murakami, Hiroshi Kita, Hideto Ueki, Takuto Hara, Jun Teishima, Nobuyuki Hinata, Hideaki Miyake, Masato Fujisawa, Toshiro Shirakawa

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SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocolsResearch in context by Moreno Ursino, Guillermo Villacampa, Jan Rekowski, Munyaradzi Dimairo, Olga Solovyeva, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Thomas R. Jeffry Evans, Elizabeth Garrett-Mayer, Robert M. Golub, Christina Guo, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Adrian Mander, Lynley V. Marshall, James Matcham, Dhrusti Patel, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Mahtab Rouhifard, Lesley Seymour, Yoshiya Tanaka, Christopher J. Weir, Johann de Bono, Christina Yap

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CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trialsResearch in context by Jan Rekowski, Christina Guo, Olga Solovyeva, Munyaradzi Dimairo, Mahtab Rouhifard, Dhrusti Patel, Emily Alger, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Johann de Bono, Thomas R. Jeffry Evans, Elizabeth Garrett–Mayer, Robert M. Golub, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Israel Maia, Adrian Mander, Lynley V. Marshall, James Matcham, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Lesley Seymour, Yoshiya Tanaka, Moreno Ursino, Christopher J. Weir, Christina Yap

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Phase I study of BC001, a novel fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor‐2, in advanced solid tumors by Dan Liu, Jifang Gong, Muling Liu, Huan Zhou, Shumei Wang, Jian Yang, Chenwei Shang, Xinlei Guo, Cha Wang, Yanqiao Zhang, Lin Shen

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Minute Ventilation/Carbon Dioxide Production Slope Could Predict Short- and Long-Term Prognosis of Patients After Acute Decompensated Heart Failure by Sheng-Hui Tuan, I-Ching Huang, Wei-Chun Huang, Guan-Bo Chen, Shu-Fen Sun, Ko-Long Lin

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A phase 1 randomized controlled trial of a peptide-based group A streptococcal vaccine in healthy volunteers by Vanessa Meier-Stephenson, Michael T. Hawkes, Catherine Burton, Ainslie Calcutt, Chris Davis, Jessica Dooley, Michael Good, Michael Houghton, Eloise Keeffe, Kelly Kim, Ailin Lepletier, Conar O’Neil, Ijeoma Ogbuehi, Victoria Ozberk, Manisha Pandey, Simone Reynolds, Avi Seth, William Stokes, Alena Tse-Chang, Ben Tyrrell, D. Lorne Tyrrell, Gregory J. Tyrrell, Maryna Yaskina

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Safety and efficacy of selective RIPK1 inhibitor SIR1-365 in hospitalized patients with severe COVID-19: A multicenter, randomized, double-blind, phase 1b trial by Norberto Chavez-Tapia, Muneeba Ahsan Sayeed, Shobha Luxmi, Douglas J. Kasper, Fenchao Xue, Yang Shen, Weiliang Fan, Wei Yuan, Bin Du

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