Clinical trial · Interventional
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
NCT07186452CI-TRIAL-00101026recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-20093 | Drug | — | UNRESOLVED |
| Itraconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS-20093 + Itraconazole
- interventionNames
- Drug: HS-20093
- Drug: Itraconazole
Primary outcomes (2)
- measure
- Cmax of HS-20093 and free toxin
- timeFrame
- Three treatment cycles, each cycle lasting for three weeks.
- description
- Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods.
- measure
- AUC0-16d of HS-20093 and free toxin
- timeFrame
- Three treatment cycles, each cycle lasting for three weeks.
- description
- 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 outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.