Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors
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
Hansoh BioMedical R&D Company
18 participants
Sep 23, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria2
- Patients with a contraindication for receiving itraconazole according to the prescribing information
- Patients with severe, uncontrolled, or active cardiovascular diseases
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07186452