Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT07186452
- Lead Sponsor
- Hansoh BioMedical R&D Company
- Brief 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HS-20093 + Itraconazole HS-20093 - HS-20093 + Itraconazole Itraconazole -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Tmax of HS-20093 and free toxin Three treatment cycles, each cycle lasting for three weeks. 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 Three treatment cycles, each cycle lasting for three weeks. Terminal elimination half-life of HS-20093 and free toxin.
AUC0-∞ and AUC0-tau of HS-20093 and free toxin Three treatment cycles, each cycle lasting for three weeks. 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 Three treatment cycles, each cycle lasting for three weeks. Minimum observed concentration of HS-20093 and free toxin.
CL of HS-20093 and free toxin Three treatment cycles, each cycle lasting for three weeks. Clearance of HS-20093 and free toxin.
V of HS-20093 and free toxin Three treatment cycles, each cycle lasting for three weeks. Volume of distribution of HS-20093 and free toxin.
Incidence and severity of adverse events (AEs) Screening to 90 days post-last dose 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.