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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20093 + Itraconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20093 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of HS-20093 and free toxin | Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods. | 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. | Three treatment cycles, each cycle lasting for three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three treatment cycles, each cycle lasting for three weeks. |
| t1/2 of HS-20093 and free toxin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21 |
|
Terminal elimination half-life of HS-20093 and free toxin.
| 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. | 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. | Three treatment cycles, each cycle lasting for three weeks. |
| CL of HS-20093 and free toxin | Clearance of HS-20093 and free toxin. | 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. | 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. | Screening to 90 days post-last dose |
| D010879 |
| Piperazines |