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;
Sequential
ST-1898 tablets
DrugSupplied as 5 mg and 40 mg tablets
Phase Ib Dose Escalation: 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
Phase Ib Dose Escalation: Recommended Phase 2 Dose (RP2D)
RP2D was determined according to MTD. MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first cycle (21days) of treatment.
Phase II Expansion: Objective Response Rate (ORR)
ORR is defined as the percentage of participants who experience a CR or PR based on RECIST 1.1 (CR: Complete Response, Disappearance of all target lesions, PR: Partial Response, At least a 30% decrease in the sum of diameters of target lesions)
Phase Ib Dose Escalation: Trough concentration of ST-1898
To assess plasma pharmacokinetics (PK) of oral administration of ST-1898
Phase Ib Dose Escalation: Peak concentration of ST-1898
To assess plasma pharmacokinetics (PK) of oral administration of ST-1898
Phase Ib Dose Escalation: ORR
Objective Response Rate (ORR) per RECIST 1.1
Phase Ib Dose Escalation: PFS
Progression-Free Survival (PFS) per RECIST 1.1
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