ST-1898, a multi-targeted tyrosine kinase inhibitor, has demonstrated strong inhibitory activity for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT, etc. The primary purpose of this study is to evaluate the efficacy of ST-1898 tablets in patients with locally advanced or metastatic RAIR-DTC after failure of at least first-line TKI systemic therapy. All subjects will receive ST-1898 180 mg orally once daily until disease progression or intolerable toxicity.
Age >= 18 years
Life expectancy of twelve weeks or more
Histologically or cytologically confirmed locally advanced or metastatic DTC that cannot be removed by surgery or radiotherapy, including papillary thyroid cancer, follicular thyroid cancer, hurthle cell thyroid cancer or poorly differentiated thyroid cancer.
At least one measurable lesion according to RECIST 1.1
Other histological subtypes of thyroid cancers excluding DTC (such as Anaplastic Thyroid Carcinoma and Medullary Thyroid Carcinoma).
Known hypersensitivity to any component of ST-1898 tablets.
Participants who have received any antitumor treatment within 4 weeks or 5 half-lives of the agent (contingent on the shorter time) prior to the first dose of study drug.
Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of study drug.
Single group
ST-1898 tablets
DrugTablets: 5 mg and 40 mg
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who have had a PR or CR as assessed by the RECIST 1.1. (CR: Complete Response, Disappearance of all target lesions, PR: Partial Response, \>=30% decrease in the sum of the longest diameters of target lesions). Overall Response (OR) = CR + PR
The number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs)
AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.
PFS
Progression-Free Survival (PFS) per RECIST 1.1
PFS6m
PFS6m per RECIST 1.1
DCR
Disease Control Rate (DCR) per RECIST 1.1
Click on the lead sponsor to view all of their trials.
