Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid … (NCT06359847) | Clinical Trial Compass
RecruitingPhase 2
Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer
China60 participantsStarted 2023-11-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Radioiodine-refractory (RAI-refractory) differentiated thyroid cancer can be diagnosed when any of the following criteria are met under thyroid-stimulating hormone (TSH) stimulation (\>30 mU/L) in the absence of exogenous iodine interference:
✓. Subjects with DTC who failed with or was intolerant to at least one prior tyrosine kinase inhibitor (TKI) therapy. If prior treatment with VEGFR-TKI, no more than two VEGFR-TKIs were allowed.
✓. Recommendation of subject offering archived tissue sample or previous biomarker of MET test report. If archived tumor sample is not available, a fresh biopsy is optional, which need to be taken from needle biopsy or core needle biopsy (fine needle biopsy not allowed). Subjects who cannot provide tissue samples or test reports may still be eligible to participate if the investigator determines a potential clinical benefit from ST-1898 therapy.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
✕. 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.
✕. ≥ grade 3 bleeding episodes within 6 months prior to first dose of study treatment, or currently ≥ grade 2 hemorrhage, with high bleeding risks (such as coagulation disorders, tracheobronchial infiltration with significant bleeding, active gastrointestinal ulcer and esophageal varices)
✕. Active hemoptysis or more than 0.5 teaspoon (2.5 mL) of hemoptysis per day within 2 months before first dose of study treatment
✕. Subjects with antiplatelet agents treatment (low-dose aspirin ≤100 mg/day is permitted).