Status:
NOT_YET_RECRUITING
Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 a...
Eligibility Criteria
Inclusion
- 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
- Patients with a contraindication for receiving itraconazole according to the prescribing information
- Patients with severe, uncontrolled, or active cardiovascular diseases
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07186452
Start Date
September 30 2025
End Date
August 31 2026
Last Update
September 22 2025
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