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

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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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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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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 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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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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Safety and Intranasal Retention of a Broad-Spectrum Anti-SARS-CoV-2 Monoclonal Antibody SA55 Nasal Spray in Healthy Volunteers: A Phase I Clinical Trial by Chaoying Hu, Yibo Zhou, Xing Meng, Jianhua Li, Jinxia Chen, Zhifang Ying, Xiaoliang Sunney Xie, Yaling Hu, Yunlong Cao, Ronghua Jin

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