A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial Tumors

Summary

This is a single-arm, phase II study to evaluate the efficacy and safety of Sacituzumab Tirumotecan, a TROP2-directed antibody-drug conjugate, in patients with advanced thymic epithelial tumors who have received second-line or later therapy.

Timeline

Start

2025-12-22

Primary completion

2027-12-22

Completion

2029-12-22

Publications

• Background Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Flechon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos CE, Pouessel D, Sternberg CN, Hong Q, Goswami T, Itri LM, Grivas P. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.
• Background Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Gomez Pardo P, Jhaveri KL, Delaney R, Valdez T, Wang H, Motwani M, Yoon OK, Verret W, Tolaney SM. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1423-1433. doi: 10.1016/S0140-6736(23)01245-X. Epub 2023 Aug 23.
• Background Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.
• Background Lombardi P, Filetti M, Falcone R, Altamura V, Paroni Sterbini F, Bria E, Fabi A, Giannarelli D, Scambia G, Daniele G. Overview of Trop-2 in Cancer: From Pre-Clinical Studies to Future Directions in Clinical Settings. Cancers (Basel). 2023 Mar 13;15(6):1744. doi: 10.3390/cancers15061744.
• Background Dum D, Taherpour N, Menz A, Hoflmayer D, Volkel C, Hinsch A, Gorbokon N, Lennartz M, Hube-Magg C, Fraune C, Bernreuther C, Lebok P, Clauditz TS, Jacobsen F, Sauter G, Uhlig R, Wilczak W, Steurer S, Minner S, Marx AH, Simon R, Burandt E, Krech T, Luebke AM. Trophoblast Cell Surface Antigen 2 Expression in Human Tumors: A Tissue Microarray Study on 18,563 Tumors. Pathobiology. 2022;89(4):245-258. doi: 10.1159/000522206. Epub 2022 Apr 27.
• Background Ardeshir-Larijani F, Maniar R, Goyal S, Loehrer PJ, Hou T, DeBrock V, Mesa H. Trop-2 Expression and Its Impact on Survival in Thymic Epithelial Tumors: Brief Report. Clin Lung Cancer. 2024 Mar;25(2):180-185.e1. doi: 10.1016/j.cllc.2024.01.001. Epub 2024 Jan 2. No abstract available.
• Background Kurokawa K, Asao T, Hayashi T, Kishikawa S, Kanamori K, Shukuya T, Miyashita Y, Nakamura I, Miyawaki T, Kanemaru R, Mimori T, Mitsuishi Y, Tajima K, Shimada N, Takahashi F, Takamochi K, Suzuki K, Takahashi K. Trophoblast Cell Surface Antigen 2 Expression in Thymic Carcinoma: Brief Report. JTO Clin Res Rep. 2024 May 29;5(7):100693. doi: 10.1016/j.jtocrr.2024.100693. eCollection 2024 Jul.
• Background Yeung V, Zaemes J, Yeh J, Giancarlo C, Ahn J, Reuss JE, Kallakury BV, Liu SV, Duttargi A, Khan G, Kim C. High levels of expression of Trop-2 in thymic epithelial tumors. Lung Cancer. 2023 Oct;184:107324. doi: 10.1016/j.lungcan.2023.107324. Epub 2023 Aug 9.
• Background Huang Q, Zhu L, Liu Y, Zhang Y. Thymic epithelial tumor medical treatment: A narrative review. Biochim Biophys Acta Rev Cancer. 2024 Sep;1879(5):189167. doi: 10.1016/j.bbcan.2024.189167. Epub 2024 Aug 6.
• Background Girard N, Ruffini E, Marx A, Faivre-Finn C, Peters S; ESMO Guidelines Committee. Thymic epithelial tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v40-55. doi: 10.1093/annonc/mdv277. No abstract available.
• Background Li Y, Jiang A, Zhao Y, Shi C, Ma Y, Fu X, Liang X, Tian T, Ruan Z, Yao Y. A novel risk classifier for predicting the overall survival of patients with thymic epithelial tumors based on the eighth edition of the TNM staging system: A population-based study. Front Endocrinol (Lausanne). 2022 Dec 6;13:1050364. doi: 10.3389/fendo.2022.1050364. eCollection 2022.
• Background Marx A, Willcox N, Leite MI, Chuang WY, Schalke B, Nix W, Strobel P. Thymoma and paraneoplastic myasthenia gravis. Autoimmunity. 2010 Aug;43(5-6):413-27. doi: 10.3109/08916930903555935.
• Background Cheng M, Anderson MS. Thymic tolerance as a key brake on autoimmunity. Nat Immunol. 2018 Jul;19(7):659-664. doi: 10.1038/s41590-018-0128-9. Epub 2018 Jun 20.
• Background Kurokawa K, Shukuya T, Greenstein RA, Kaplan BG, Wakelee H, Ross JS, Miura K, Furuta K, Kato S, Suh J, Sivakumar S, Sokol ES, Carbone DP, Takahashi K. Genomic characterization of thymic epithelial tumors in a real-world dataset. ESMO Open. 2023 Oct;8(5):101627. doi: 10.1016/j.esmoop.2023.101627. Epub 2023 Sep 12.
• Background Radovich M, Pickering CR, Felau I, Ha G, Zhang H, Jo H, Hoadley KA, Anur P, Zhang J, McLellan M, Bowlby R, Matthew T, Danilova L, Hegde AM, Kim J, Leiserson MDM, Sethi G, Lu C, Ryan M, Su X, Cherniack AD, Robertson G, Akbani R, Spellman P, Weinstein JN, Hayes DN, Raphael B, Lichtenberg T, Leraas K, Zenklusen JC; Cancer Genome Atlas Network; Fujimoto J, Scapulatempo-Neto C, Moreira AL, Hwang D, Huang J, Marino M, Korst R, Giaccone G, Gokmen-Polar Y, Badve S, Rajan A, Strobel P, Girard N, Tsao MS, Marx A, Tsao AS, Loehrer PJ. The Integrated Genomic Landscape of Thymic Epithelial Tumors. Cancer Cell. 2018 Feb 12;33(2):244-258.e10. doi: 10.1016/j.ccell.2018.01.003.
• Background Marx A, Chan JKC, Chalabreysse L, Dacic S, Detterbeck F, French CA, Hornick JL, Inagaki H, Jain D, Lazar AJ, Marino M, Marom EM, Moreira AL, Nicholson AG, Noguchi M, Nonaka D, Papotti MG, Porubsky S, Sholl LM, Tateyama H, Thomas de Montpreville V, Travis WD, Rajan A, Roden AC, Strobel P. The 2021 WHO Classification of Tumors of the Thymus and Mediastinum: What Is New in Thymic Epithelial, Germ Cell, and Mesenchymal Tumors? J Thorac Oncol. 2022 Feb;17(2):200-213. doi: 10.1016/j.jtho.2021.10.010. Epub 2021 Oct 22.
• Background Xu C, Zhang Y, Wang W, Wang Q, Li Z, Song Z, Wang J, Yu J, Liu J, Zhang S, Cai X, Wu M, Zhan P, Liu H, Lv T, Miao L, Min L, Li J, Liu B, Yuan J, Jiang Z, Lin G, Chen X, Pu X, Rao C, Lv D, Yu Z, Li X, Tang C, Zhou C, Zhang J, Guo H, Chu Q, Meng R, Liu X, Wu J, Hu X, Fang M, Zhou J, Zhu Z, Chen X, Pan W, Pang F, Zhou Y, Jian Q, Wang K, Wang L, Zhu Y, Yang G, Lin X, Cai J, Liang L, Feng H, Wang L, Du Y, Yao W, Shi X, Niu X, Yuan D, Yao Y, Huang J, Zhang Y, Sun P, Wang H, Ye M, Wang D, Wang Z, Hao Y, Wang Z, Wan B, Lv D, Yu G, Li A, Kang J, Zhang J, Zhang C, Chen H, Shi L, Ye L, Wang G, Wang Y, Gao F, Zhou W, Hu C, Wei J, Li B, Li Z, Li Y, Liu Z, Yang N, Wu L, Wang Q, Huang W, Hong Z, Wang G, Fang M, Fang Y, Zhu X, Du K, Ji J, Shen Y, Zhang Y, Ma S, Song Y, Lu Y, Liu A, Fang W, Zhong W. Chinese expert consensus on the diagnosis and treatment of thymic epithelial tumors. Thorac Cancer. 2023 Apr;14(12):1102-1117. doi: 10.1111/1759-7714.14847. Epub 2023 Mar 16.
• Background Gerber TS, Strobl S, Marx A, Roth W, Porubsky S. Epidemiology of thymomas and thymic carcinomas in the United States and Germany, 1999-2019. Front Oncol. 2024 Jan 9;13:1308989. doi: 10.3389/fonc.2023.1308989. eCollection 2023.

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Indications