OncoMatch/Clinical Trials/NCT06359860
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Is NCT06359860 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ST-1898 tablets for unresectable or metastatic melanoma.
Treatment: ST-1898 tablets — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: conventional therapy
acral melanoma that was progressed with conventional therapy
Cannot have received: antitumor therapy
A history of antitumor therapy within 4 weeks, including chemotherapy, radiotherapy, biotherapy, endocrine therapy or immunotherapy, etc.
Cannot have received: oral fluoropyrimidines and small molecular targeted-drug therapy
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）
Cannot have received: traditional Chinese medicine with antitumor indication
A history of traditional Chinese medicine with antitumor indication within 2 weeks
Lab requirements
Blood counts
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
Kidney function
Serum creatinine ≤1.5 × upper limit of normal (ULN)
Liver function
AST/ALT ≤ 2.5 ULN, AST/ALT ≤ 5 ULN for liver metastasis; Total bilirubin ≤ 1.5 ULN; Serum albumin ≥30 g/L
Cardiac function
QTc (by Fridericia): male >450 ms, female >470 ms; Left ventricular ejection fraction（LVEF）<50%; Uncontrolled hypertension (blood pressure≥140/90 mmHg even with antihypertensive therapy); New York Heart Association Class ≥ II
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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