The primary objective of this study is to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors.
Histologically or cytologically confirmed advanced solid tumors that have failed standard therapy or are intolerant to standard treatment.
According to RECIST 1.1 criteria, participants must have at least one target lesion.
ECOG performance status score of 0-1 with no deterioration within 2 weeks prior to the first dose.
Minimum expected survival greater than 12 weeks.
Patients with a contraindication for receiving itraconazole according to the prescribing information
Patients with severe, uncontrolled, or active cardiovascular diseases
Single group
HS-20093
DrugAll participants will receive intravenous infusion of HS-20093 at a dose of 8 mg/kg every 3 weeks (Q3W), with each treatment cycle lasting 21 days.
Itraconazole
DrugParticipants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21
Cmax of HS-20093 and free toxin
Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods.
AUC0-16d of HS-20093 and free toxin
Area under the concentration-time curve from time zero to 16 days of HS-20093 and free free toxin, calculated by non-compartmental analysis.
Tmax of HS-20093 and free toxin
Time to reach maximum concentration of HS-20093 and free toxin, derived directly from observed concentration-time data.
t1/2 of HS-20093 and free toxin
Terminal elimination half-life of HS-20093 and free toxin.
AUC0-∞ and AUC0-tau of HS-20093 and free toxin
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) and during the dosing interval (AUC0-tau) of HS-20093 and free toxin.
Cmin of HS-20093 and free toxin
Minimum observed concentration of HS-20093 and free toxin.
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