Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS-20093, Itraconazole.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors Who Have Failed Adequate Standard Treatments or Are Intolerant to Standard Therapies
Overview
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
- Drug 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. - Drug Itraconazole
Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21
Primary outcome measures
- Cmax of HS-20093 and free toxin [Time frame: Three treatment cycles, each cycle lasting for three weeks.]
- AUC0-16d of HS-20093 and free toxin [Time frame: Three treatment cycles, each cycle lasting for three weeks.]
Secondary outcome measures (7)
- Tmax of HS-20093 and free toxin [Time frame: Three treatment cycles, each cycle lasting for three weeks.]
- t1/2 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 [Time frame: Three treatment cycles, each cycle lasting for three weeks.]
- Cmin of HS-20093 and free toxin [Time frame: Three treatment cycles, each cycle lasting for three weeks.]
- CL of HS-20093 and free toxin [Time frame: Three treatment cycles, each cycle lasting for three weeks.]
- V of HS-20093 and free toxin [Time frame: Three treatment cycles, each cycle lasting for three weeks.]
- Incidence and severity of adverse events (AEs) [Time frame: Screening to 90 days post-last dose]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patients with a contraindication for receiving itraconazole according to the prescribing information
- Patients with severe, uncontrolled, or active cardiovascular diseases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hunan Cancer Hospital — Changsha
Identifiers
NCT: NCT07186452 · HS-20093-111