How itraconazole affects HS-20093 levels in people with advanced solid tumors
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
Run by Hansoh BioMedical R&D Company · NCT07186452 · Data updated 2026-11-12
This test will see if taking oral itraconazole changes how the experimental cancer drug HS-20093 is processed in people with advanced solid tumors who have not responded to standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | September 23, 2025 |
| Main results expected | July 31, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07186452 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically or cytologically confirmed advanced solid tumors who have failed or are intolerant to standard treatments, have at least one measurable lesion, ECOG 0–1, and expected survival greater than 12 weeks are the intended participants.
✕Probably not a fit
Patients who are responding to standard therapies, have contraindications to itraconazole, or have severe uncontrolled cardiovascular disease are unlikely to qualify or gain therapeutic benefit from this PK-focused protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label, non-randomized, fixed-sequence study gives all participants intravenous HS-20093 (8 mg/kg every three weeks) and then adds oral itraconazole (200 mg) during a defined window to measure drug interactions. It is self-controlled, so each participant serves as their own comparator for pharmacokinetic (PK) measurements. The trial enrolls adults with advanced solid tumors who have failed or are intolerant to standard therapies, require at least one measurable lesion per RECIST 1.1, and have ECOG performance status 0–1. Intensive blood sampling will compare HS-20093 levels before and after itraconazole to define changes in exposure, metabolism, and elimination.
Why it matters
Potential benefit: If co-administration changes HS-20093 exposure, the results could guide safer dosing and interaction warnings for patients who need both medications.
How similar studies have gone: Using itraconazole as a potent CYP3A inhibitor to probe drug-drug interactions is a well-established approach that has successfully informed dosing for other oncology drugs, though HS-20093 itself is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hunan Cancer Hospital
Changsha, Hunan, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.