Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)

Summary

The goal of this clinical trial is to learn if the drug, sacituzumab govitecan, works to treat: 1. Salivary gland cancers that have spread to other parts of the body or come back after previous treatment, and cannot be removed by surgery 2. A type of thyroid cancer (specifically, differentiated thyroid carcinoma) that has spread to other parts of the body or come back after previous treatment, no longer responds to radioactive iodine treatment and cannot be removed by surgery The main question it aims to answer is whether sacituzumab govitecan can treat the 2 conditions mentioned above in a safe and effective manner. Participants will: * Receive sacituzumab govitecan by intravenous (IV) infusion on Day 1 and Day 8 of each treatment cycle. Each treatment cycle is 21 days (3 weeks) long. * Visit the clinic before each infusion for checkups and blood tests * Go through CT/PET/MRI scan once every 6 weeks for the first 24 weeks, then every 9 weeks thereafter. * Go through 2 tumour biopsies (if assessed by the doctor to be safe) at the start and at the end of study participation Participants will continue to receive treatment with sacituzumab govitecan until their cancer stops responding to the drug or if they decide to withdraw from the study.

Timeline

Start

2025-04-15

Primary completion

2030-04

Completion

2030-04

Publications

• Background Cubas R, Zhang S, Li M, Chen C, Yao Q. Trop2 expression contributes to tumor pathogenesis by activating the ERK MAPK pathway. Mol Cancer. 2010 Sep 21;9:253. doi: 10.1186/1476-4598-9-253.
• Background Schlumberger M, Brose M, Elisei R, Leboulleux S, Luster M, Pitoia F, Pacini F. Definition and management of radioactive iodine-refractory differentiated thyroid cancer. Lancet Diabetes Endocrinol. 2014 May;2(5):356-8. doi: 10.1016/S2213-8587(13)70215-8. Epub 2014 Jan 30. No abstract available.
• Background Shulin JH, Aizhen J, Kuo SM, Tan WB, Ngiam KY, Parameswaran R. Rising incidence of thyroid cancer in Singapore not solely due to micropapillary subtype. Ann R Coll Surg Engl. 2018 Apr;100(4):295-300. doi: 10.1308/rcsann.2018.0004. Epub 2018 Mar 15.
• Background Mahmood U, Koshy M, Goloubeva O, Suntharalingam M. Adjuvant radiation therapy for high-grade and/or locally advanced major salivary gland tumors. Arch Otolaryngol Head Neck Surg. 2011 Oct;137(10):1025-30. doi: 10.1001/archoto.2011.158.
• Background Licitra L, Cavina R, Grandi C, Palma SD, Guzzo M, Demicheli R, Molinari R. Cisplatin, doxorubicin and cyclophosphamide in advanced salivary gland carcinoma. A phase II trial of 22 patients. Ann Oncol. 1996 Aug;7(6):640-2. doi: 10.1093/oxfordjournals.annonc.a010684.
• Background Guan H, Guo Z, Liang W, Li H, Wei G, Xu L, Xiao H, Li Y. Trop2 enhances invasion of thyroid cancer by inducing MMP2 through ERK and JNK pathways. BMC Cancer. 2017 Jul 14;17(1):486. doi: 10.1186/s12885-017-3475-2.
• 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 Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31.

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Indications