PO.CT01.01 · 临床试验
Phase 0 and First-in-Human Phase I Clinical Trials
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- CT111 CT111 FX-909治疗膀胱癌的0期瘤内微装置研究显示出靶向抗肿瘤活性和免疫调节作用，且与抗PD-1联用时增强 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
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- CT114 CT114 GIGA-564(一种新型瘤内Treg清除型抗CTLA-4抗体)治疗晚期或转移性实体瘤的1a/1b期初步结果 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 CT115 LYC001，一种用于淋巴结靶向IL-2免疫治疗的高亲和力分级组装体：强效抗肿瘤免疫的临床前验证及首次人体Ia期研究的初步安全性 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
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- CT118 CT118 JBZ-001（HOSU-53）的临床药代动力学和药效动力学：首次人体数据与转化性临床前预测的比较 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 CT120 BGB-24714（一种第二线粒体来源的半胱天冬酶激活剂（SMAC）模拟物）作为单药或与化疗或同步放化疗联合治疗实体瘤的1期研究 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 CT121 BGB-24714（一种第二线粒体来源的半胱天冬酶激活剂（SMAC）模拟物）在实体瘤首次人体研究中的药效动力学（PD）特征分析 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 CT122 EVM16（一种个性化mRNA新抗原疫苗）作为单药及与替雷利珠单抗联合治疗晚期实体瘤的首次人体（FIH）研究 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
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- CT124 CT124 评估Fas配体（FasL）阻断抗体M3T01用于晚期难治性实体瘤成人患者的I期临床试验中期结果 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
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- CT128 CT128 EGFR/HER3靶向双特异性抗体-药物偶联物（ADC）JS212在晚期实体瘤患者中的首次人体I/II期研究初步结果 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 CT129 pan-RAF-MEK分子胶NST-628在晚期或难治性RAF、KRAS和NRAS突变实体瘤患者中的1a/b期剂量递增和扩展试验初步结果 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 CT130 巨噬细胞激活型抗CD24抗体PHST001在晚期/转移性实体瘤患者中的1期研究初步结果 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 CT131 二酰甘油激酶alpha（DGKalpha）选择性细胞内T细胞检查点抑制剂BAY2862789在实体瘤中的全球首次人体（FiH）单药剂量递增试验 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 CT132 细胞内T细胞检查点二酰甘油激酶zeta（DGKζ）选择性抑制剂BAY2965501作为单药及与抗PD-1联合的首次人体试验 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 CT133 225 Actinium-DOTA-daratumumab（一种α粒子发射型放射免疫治疗药物）在daratumumab难治性多发性骨髓瘤患者中的首次人体试验 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
