On November 14, 2023, the registered clinical trial project “Multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the efficacy and safety of ST-1898 tablets for the treatment of locally advanced or metastatic radioiodine-refractory differentiated thyroid cancer that has failed at least one line of TKI therapy” was successfully initiated at Peking Union Medical College Hospital (PUMC). This is the third clinical trial after ST-1898 tablets started clinical trials in the fields of kidney cancer and melanoma.
Prof. Lin Yansong of Peking Union Medical College Hospital (PUMC), the lead PI of this project, chaired the kick-off meeting. The incidence of thyroid cancer is on the rise year by year worldwide, especially in China where annual new cases of thyroid cancer account for more than one-third of the global cases, while the risk of death is higher than that in Europe and the United States. The U.S. SEER database shows that the 5-year survival rate of thyroid cancer can be up to 98.5%, but the data published in 2018 in China shows that the 5-year survival rate of thyroid cancer is only 84.3%. This also suggests that Chinese thyroid cancer patients still face a threat to their survival. Nearly two-thirds of patients with differentiated thyroid cancer, which accounted for 95% of thyroid cancer, had distant metastatic lesions that gradually did not ingest iodine at the beginning or during treatment and responded poorly to RAI therapy, presenting an iodine-refractory status. The diagnosis and treatment of iodine-refractory thyroid cancer has been a hotspot of global concern. Although first-line tyrosine kinase inhibitor (TKI) treatments such as Lenvatinib and Donafenib are available at present, their control of the disease and the time of remission are limited, and at present, there is no standard second-line treatment plan for the patients who are refractory to the first-line TKI treatments in our country, and due to the rapid progression of this part of the patients, the increased risk of death has become a clinical difficulty, new treatment means are urgently needed.
ST-1898 tablets can highly inhibit targets closely related to the occurrence, development and metastasis of thyroid cancer and other tumors, including vascular endothelial growth factor receptor (VEGFR), hepatocyte growth factor receptor (MET), and microvessel-associated protein receptor (RET), etc. So as to inhibit multiple signaling pathways, directly and indirectly inhibit the growth and migration of tumor cells, and promote the apoptosis of tumor cells, it can directly and indirectly inhibit tumor cell growth and migration, promote tumor cell apoptosis, and inhibit the growth and metastasis of thyroid cancer and other tumors through combined action and synergistic mechanisms.
After the initiation of the clinical trial, it is expected that more subjects with first-line drug-resistant iodine-refractory thyroid cancer will benefit from treatment with ST-1898 tablets, and to provide a new treatment option for patients with refractory thyroid cancer in China.
About ST-1898 Tablets
ST-1898 Tablet is a small molecule multi-target tyrosine kinase inhibitor independently developed by Scitech Pharma through its proprietary AI drug design platform (SigmaHit®) with global intellectual property rights, capable of inhibiting c-MET, VEGFR-2, PDGFRa, RET, c-KIT, TRK-A, TRK-B, AXL and other targets, which was approved by the National Medical Products Administration (NMPA) in July 2020 to conduct clinical trials. In the Phase I clinical trial, ST-1898 tablets have demonstrated good safety and preliminary efficacy in a variety of tumors, including liver, lung, thyroid, gallbladder and intestinal cancers. Currently, Phase II melanoma and Phase II advanced renal cell carcinoma clinical trials are being conducted simultaneously at Beijing Cancer Hospital with significant efficacy and excellent safety observed, in which it meets the original intention of drug design. The initiation of this clinical trial for thyroid cancer signifies the therapeutic potential of ST-1898 tablets for a wide range of indications and broad application prospects.
Scitech Pharma
