ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.
In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.
In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets.
Age >= 18 years
Life expectancy of three months or more
Histologically or cytologically confirmed unresectable or metastatic stage III or IV acral melanoma that was progressed with conventional therapy
Recommendation of subject offering archived tissue sample or previous biomarker 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 with one of the following conditions prior to first dose, including, but not limiting to：
A history of antitumor therapy within 4 weeks, including chemotherapy, radiotherapy, biotherapy, endocrine therapy or immunotherapy, etc.;
A history of oral fluoropyrimidines and small molecular targeted-drug therapy within 2 weeks or 5 half-life time （the longer time taken as final）;
A history of traditional Chinese medicine with antitumor indication within 2 weeks;