Advanced Solid Tumors
Conditions
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
Interventions
DRUGHS-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.
DRUGItraconazole
Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| CL of HS-20093 and free toxin | Three treatment cycles, each cycle lasting for three weeks. | Clearance of HS-20093 and free toxin. |
| 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. |
Countries
China
Outcome results
None listed