Phase 0 and First-in-Human Phase I Clinical Trials

• CT109 · PDF ­A phase 0/1 study of PRMT5 inhibitor BMS-986504 in recurrent glioblastoma participants with MTAP deletion Nader Sanai, Shwetal Mehta, Artak Tovmasyan, Jocelyn Harmon, Hualin Zhang, Amy Hong, Nadia Gonzalez, Tearra Sheidler, Brian Pham, Yoshie Umemura, William Knight, Tigran Margaryan, An-Chi Tien
• CT111 Phase 0 intratumoral microdevice study of FX-909 in bladder cancer demonstrates on-target anti-tumor activity and immune modulation, enhanced in combination with anti-PD-1 Phuong A. Nguyen, Peter M. Szabo, Joseph Kotler, Simon Chow, Bijal Kakrecha, Nnamdi Onochie, Fanni Santa, Michaela Bowden, Oliver Jonas, Matthew Mossanen, Evisa Gjini
• CT112 · PDF Clinical validation of a first-in-class pan-cancer antibody Vartumab targeting oncofetal chondroitin sulfate Mads Daugaard, Tobias Gustavsson, Elena E. Vidal-Calvo, Swati Choudhary, Robert Dagil, Anne-Fleur S. Verhaar, Noortje C. van Dijk, Hendrikus H. B. Boersma, Andor W.J.M. Glaudemans, Danielle J. Vugts, Daniël Waagmeester, Yester Janssen, Maarten Brom, Frederico M. Pimenta, Gooitzen M. van Dam, Ali Salanti
• CT114 Preliminary phase 1a/1b results of GIGA-564, a novel intratumoral Treg-depleting anti-CTLA-4 antibody, in advanced or metastatic solid tumors Laercio DaSilva, Jason M. Redman, Olga Titova, Anne-Marie Duggan, Victoria Jeffers, Erica Redmond, Ruchi Patel, Hoyoung M. Maeng, Nicholas Tschernia, Jennifer L. Marte, Renee N. Donahue, Evrim B. Turkbey, Daniel Prins, Wiem Lassoued, Manuk Manukyan, Michell Manu, Jeffrey Schlom, Charalampos S. Floudas, Kim Hanna, Erica Lyn Stone, James L. Gulley
• CT115 LYC001, a high-affinity hierarchical assembly for lymph node-targeted IL-2 immunotherapy: Preclinical validation of potent antitumor immunity and preliminary safety from the first-in-human phase Ia study Shuhang Wang, Dongyan Liu, Yanjie Han, Mingzhen Li, Wenfeng Zeng, Wei Liang, Ning Li
• CT116 · PDF Data-driven characterization of platelet count and alanine aminotransferase dynamics in the first-in-human LP-184 dose escalation trial Jianli Zhou, Daruka Mahadevan, Jay Parekh, Marc Chamberlain, Kishor Bhatia, Reginald Ewesuedo
• CT117 · PDF Phase 1 study of HRS-6209, a highly selective CDK4 inhibitor, in patients with advanced solid tumors Jiong Wu, Jian Zhang, Ning Lu, Caigang Liu, Qiang Ding, Huangming Hong, Hui Wang, Yuping Sun, Hong Zhang, Min Yan, Ying Wang, Yiqun Du, Yanchun Meng, Dongfang Li, Huihui Li, Zhengkui Sun, Xiaoyu Zhu, Xia Zhang, Xiaonan Sheng, Qiushi Xie, Mengzhu Yu
• CT118 Clinical pharmacokinetic and pharmacodynamic of JBZ-001 (HOSU-53): Comparison of first-in-human data with translational preclinical predictions Min Hai, Nicole Abbott, James O. Larkin, Zhiliang Xie, Christopher Coss, Tamara Jovonovich, Zuzana J. Trnkova, Philippa Graham, William B. McKean, Asrar A. Alahmadi, Mitch Phelps
• CT120 A phase 1 study of BGB-24714, a second mitochondrial-derived activator of caspases (SMAC) mimetic, as monotherapy or in combination with chemotherapy or concurrent chemoradiotherapy in solid tumors Andreas Varkaris, Erika Hamilton, Jermaine Coward, Rafael Santana-Davila, Jinming Yu, Byoung Chul Cho, Jung Yun Lee, Yongsheng Li, Sanjeev Deva, Youngjoo Lee, Huai Liu, Yuping Sun, Zhe Yang, Wen Xu, Sook Ryun Park, Se-Hoon Lee, Andrew Z. Wang, Hui Shao, Jinhui Zhang, Zhaoyin Zhu, Runzhe Chen, Hua-Xin Gao, Judy S. Wang
• CT121 Pharmacodynamic (PD) characterization of BGB-24714, a second mitochondrial-derived activator of caspases (SMAC) mimetic, in a first-in-human study in solid tumors Jinhui Zhang, Minjuan Deng, Bin Jiang, Jie Li, Judy Wang, Erika Hamilton, Hua-Xin Gao, Xiaomin Song, Zhirong Shen, Wei Jin, Fernando Doñate
• CT122 First-in-human (FIH) study of EVM16, a personalized mRNA neoantigen vaccine, as monotherapy and combination with tislelizumab in advanced solid tumors Tong Xie, Jian Zhang, Yanchun Meng, Xu Jia, Yue Fan, Li Wang, Jennifer Yang, Sandra Zeng, Hongxia Wang, Lin Shen
• CT123 · PDF Immune escape via myeloid-derived suppressor cells in solid tumor cancer patients treated with anchored IL-12? (tolododekin alfa) Wiem Lassoued, Sailaja Battula, Lisa Sturla, Jong C. Park, Brendan Curti, Marcus O. Butler, John M. Kirkwood, Howard L. Kaufman, James L. Gulley
• CT124 Interim results of a phase I clinical trial evaluating Fas ligand (FasL) blocking antibody M3T01 in adults with advanced treatment-refractory solid tumors Rom Leidner, Prakash Ambady, Emily M. Lin, Neda Jooya, Amber Ruiz, Cassandra Niemi, Christopher Darus, Binbin Zheng-Lin, Tara Foote, Ashley Drokin, Alexander T. Tran, Grayson DuRaine, Bernard Fox, Alan Korman, William L. Redmond, Matthew H. Taylor
• CT126 · PDF Results of phase 1 first-in-human clinical trial of HMBD-002, an IgG4 monoclonal antibody targeting VISTA, in advanced solid tumors Jordi Ahnert Rodon, Joshua J. Gruber, Melinda L. Telli, Andrew Hendifar, Joseph W. Kim, Sharonlin Bhardwaj, Padmanee Sharma, Dipti Thakkar, Jerome Boyd-Kirkup, Eugene Kennedy
• CT127 · PDF First-in-human study of ES014, a bispecific antibody targeting CD39 and TGF-beta as monotherapy in patients with advanced solid tumors Sai Ge, Tong Xie, Jian Li, Yehua Zhu, Di Luo, Quan Qiu, Bin Chen, Jiayu Song, Hongtao Lu, Lin Shen
• CT128 Preliminary results from a first-in-human phase I/II study of JS212, an EGFR/HER3-targeted bispecific antibody-drug conjugate (ADC), in patients with advanced solid tumors Shun Lu, Huiping Li, Yinghua Ji, Longhua Sun, Zhangzhou Huang, Huangming Hong, Jianhua Shi, Fangling Ning, Yongmei Yin, Jian Fang, Aobing Bai, Dexuan Zhang, Zhihao Jiang, Qing Yang
• CT129 Preliminary results from a Phase 1a/b dose-escalation and expansion trial of the pan-RAF-MEK molecular glue NST-628 in patients (pts) with advanced or refractory RAF, KRAS, and NRAS-mutant solid tumors Ahmad A. Tarhini, Monica Chen, Jia Liu, Varun Monga, Victoria Atkinson, Sarina A. Piha-Paul, Bartosz Chmielowski, Benjamin Herzberg, Charlotte Lemech, Prachi Bhave, Ganessan Kichenadasse, Gerald Falchook, Janice Mehnert, Andrae Vandross, Mohamad Salkeni, Meredith McKean, David Wages, Ann Marie Kennedy, Meagan B. Ryan, John Clark, Abdulaziz Nanah, Michael J. Fossler, Philip Komarnitsky, Igor Puzanov
• CT130 Initial results from a phase 1 study of PHST001, a macrophage activating anti-CD24 antibody, in patients with advanced/metastatic solid tumors Stephane Champiat, Ulka Vaishampayan, Michael Cecchini, Oliver Dorigo, Anthony El-Khoueiry, Gina Fleming, Niharika Mettu, Michael J. Dennis, Elizabeth Davis, Susan Luebbe, Jen Cao, Roy Maute, Raphael Rousseau, Kyriakos Papadopoulos
• CT131 Global first-in-human (FiH) monotherapy dose escalation trial of BAY2862789, a diacylglycerol kinase alpha (DGKalpha) selective intra-cellular T cell checkpoint inhibitor in solid tumors Ravit Geva, Ofra Maimon, Aaron Hansen, Jeong Eun Kim, Javier Garcia-Corbacho, Enriqueta Felip, Sook Hee Hong, Kyriakos Papadopoulos, Guru Sonpavde, Alexandre Desjonqueres, Yulin Li, Christoph Mancao, Jochen Schulze, Stephen Ducray, Andrea Frohwann, Lidia Sacchetto, Huijuan Su, Laura Hunt, Stefanie Reif, David A. Schaer, Helge Roider, Leila Khoja, Shirish Madhav Gadgeel, Tae Min Kim
• CT132 First in human trial of BAY2965501, a selective inhibitor of intra-cellular T cell checkpoint diacylglycerol kinase zeta (DGKζ), as monotherapy and combination with anti-PD-1 Ruth Plummer, Anna Minchom, Ramon Yarza, Hans Prenen, Mark R Middleton, Kyriakos Papadopoulos, Hye Ryun Kim, Tatiana Hernandez, Ignacio Melero, Ignacio Ortego Zabalza, Enriqueta Felip, Seung Tae Kim, Toshihiko Doi, Keun-Wook Lee, Sarah Taylor, Debashsis Sarker, Yulin Li, Maribel Salas, Jochen Schulze, Stephen Ducray, Huijuan Su, Yuqing Xiao, Alexandre Desjonqueres, Andrea Frohwann, Bart Ploeger, Konstantin Lang, Stephanie Lapointe, Kristen Armstrong, Alison Edgar, Christoph Mancao, David A. Schaer, Stefanie Reif, Leila Khoja, Jason Henry
• CT133 First-in-human trial of 225 Actinium-DOTA-daratumumab, an alpha-emitting radioimmunotherapy, in patients with daratumumab-refractory multiple myeloma Scott Ryan Goldsmith, Vikram Adhikarla, Murali Janakiram, Michael Rosenzweig, Savita Dandapani, Sarah Lee, Nitya Nathwani, Azra Borogovac, Myo Htut, Theophilus Tandoh, Alex Pozhitkov, Enrico Caserta, Mariam Murtadha, Ni-Chun Tsai, Arnab Chowdhury, Joycelynne Palmer, Jonathan Keats, James Sanchez, Erasmus Poku, Russell Rockne, Paul Yazaki, Jeffrey Wong, John E. Shively, Flavia Pichiorri, Amrita Krishnan

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