A Phase 1 interventional study of HS-20093 and Itraconazole in Advanced Solid Tumors, sponsored by Hansoh BioMedical R&D Company. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Hansoh BioMedical R&D Company · Phase 1, Interventional, and Treatment
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.
This is a multicenter, open-label, non-randomized, fixed-sequence, self-controlled clinical study designed to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors who have failed or are intolerant to standard therapy.
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. Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21
Hansoh BioMedical R&D Company is the lead sponsor of 44 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: HS-20093 · Drug: Itraconazole
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.
Participants 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.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
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.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
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.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
t1/2 of HS-20093 and free toxin
Terminal elimination half-life of HS-20093 and free toxin.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
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.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
Cmin of HS-20093 and free toxin
Minimum observed concentration of HS-20093 and free toxin.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
CL of HS-20093 and free toxin
Clearance of HS-20093 and free toxin.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
V of HS-20093 and free toxin
Volume of distribution of HS-20093 and free toxin.
Time frame: Three treatment cycles, each cycle lasting for three weeks.
Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Time frame: Screening to 90 days post-last dose
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Hansoh BioMedical R&D Company