A Phase Ib/II Study to Evaluate the Efficacy and Safety of ST-1898 in Subjects With Unresectable or Metastatic Melanoma
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)
• Eastern Cooperative Oncology Group performance status (PS) ≤ 1
• At least one measurable lesion per RECIST 1.1
• Has adequate organ function defined as follows:
‣ Absolute neutrophil count ≥ 1.5 ×10\^9/L, Platelets ≥ 75× 10\^9/L and Hemoglobin ≥ 90 g/L (no blood transfusions, no platelet transfusions and no use of colony stimulating factor within 2 weeks prior to routine blood test) at screening;
⁃ Serum creatinine ≤1.5 × upper limit of normal (ULN)
⁃ Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 ULN, AST/ALT ≤ 5 ULN for liver metastasis;
⁃ Total bilirubin ≤ 1.5 ULN
⁃ International normalized ratio (INR) ≤ 1.5 ULN, or prothrombin time (PT) ≤1.5 ULN
⁃ Activated partial thromboplastin time (APTT) ≤1.5 ULN
⁃ Serum albumin ≥30 g/L
• Willing and able to provide written Informed consent.
• Eligible male and female subjects with fertility activity or their sexual partners must use effective contraception during study period and though 90 days after last study treatment. Women of child-bearing age must have a negative serum pregnancy test within 7 days before first study treatment