How itraconazole affects HS-20093 levels in people 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
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 |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT07186452 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.