HS-20093: All 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: Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Histologically or cytologically confirmed advanced solid tumors that have failed standard therapy or are intolerant to standard treatment.
2. According to RECIST 1.1 criteria, participants must have at least one target lesion.
3. ECOG performance status score of 0-1 with no deterioration within 2 weeks prior to the first dose.
4. Minimum expected survival greater than 12 weeks.
Exclusion Criteria:
1. Patients with a contraindication for receiving itraconazole according to the prescribing information
2. Patients with severe, uncontrolled, or active cardiovascular diseases
Primary outcome measure(s)
Cmax of HS-20093 and free toxin — Three treatment cycles, each cycle lasting for three weeks. Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods.
AUC0-16d of HS-20093 and free toxin — Three treatment cycles, each cycle lasting for three weeks. Area under the concentration-time curve from time zero to 16 days of HS-20093 and free free toxin, calculated by non-compartmental analysis.
Trial sites (1)
Facility
City
Region
Status
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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