Advanced Solid TumorsPhase 1NCT07186452
Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors
A Phase 1 study testing HS-20093 and Itraconazole in people with Advanced Solid Tumors, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HS-20093 and Itraconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to 31 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with a contraindication for receiving itraconazole according to the prescribing information
- Patients with severe, uncontrolled, or active cardiovascular diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Feng Yang, MD, 86-731-89762695, hnszlyy_irb@163.com
About this study
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
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.
Read the 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 advanced solid tumors who have failed or are intolerant to standard therapy.
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
- Conditions
- Advanced Solid Tumors
- Being tested
- HS-20093, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20093Drug
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.
ItraconazoleDrug
Participants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21
| Study group | Role | What they receive |
|---|---|---|
| HS-20093 + Itraconazole | Experimental | Not described Receives: Drug: HS-20093; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of HS-20093 and free toxin
Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods.
Measured: Three treatment cycles, each cycle lasting for three weeks.
AUC0-16d of HS-20093 and free toxin
Area under the concentration-time curve from time zero to 16 days of HS-20093 and free free toxin, calculated by non-compartmental analysis.
Measured: Three treatment cycles, each cycle lasting for three weeks.
Secondary outcomes (7)
Tmax of HS-20093 and free toxin
Time to reach maximum concentration of HS-20093 and free toxin, derived directly from observed concentration-time data.
Measured: Three treatment cycles, each cycle lasting for three weeks.
t1/2 of HS-20093 and free toxin
Terminal elimination half-life of HS-20093 and free toxin.
Measured: Three treatment cycles, each cycle lasting for three weeks.
AUC0-∞ and AUC0-tau of HS-20093 and free toxin
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) and during the dosing interval (AUC0-tau) of HS-20093 and free toxin.
Measured: Three treatment cycles, each cycle lasting for three weeks.
Cmin of HS-20093 and free toxin
Minimum observed concentration of HS-20093 and free toxin.
Measured: Three treatment cycles, each cycle lasting for three weeks.
CL of HS-20093 and free toxin
Clearance of HS-20093 and free toxin.
Measured: Three treatment cycles, each cycle lasting for three weeks.
V of HS-20093 and free toxin
Volume of distribution of HS-20093 and free toxin.
Measured: Three treatment cycles, each cycle lasting for three weeks.
Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Measured: Screening to 90 days post-last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start23 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186452
- Sponsor's protocol ID
- HS-20093-111
- Status last verified
- Jan 2026
- First submitted
- 9 Sep 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07186452
- Acronym / sponsor ID
- HS-20093-111
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 advanced solid tumors who have failed or are intolerant to standard therapy.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-20093 + Itraconazole | Experimental | Drug: HS-20093, Drug: Itraconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with a contraindication for receiving itraconazole according to the prescribing information
- Patients with severe, uncontrolled, or active cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20093All 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. | Drug | HS-20093 + Itraconazole |
| ItraconazoleParticipants will then take itraconazole capsules orally at 200 mg per dose during C2D17-C3D21 | Drug | HS-20093 + Itraconazole |
Primary outcome
Cmax of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
Maximum concentration of HS-20093 and free toxin, measured by appropriate analytical methods.
AUC0-16d of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
Area under the concentration-time curve from time zero to 16 days of HS-20093 and free free toxin, calculated by non-compartmental analysis.
7 secondary outcomes
Tmax of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
t1/2 of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
AUC0-∞ and AUC0-tau of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
Cmin of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
CL of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
V of HS-20093 and free toxin
Time frame: Three treatment cycles, each cycle lasting for three weeks.
Incidence and severity of adverse events (AEs)
Time frame: Screening to 90 days post-last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-20093 and Itraconazole in people with Advanced Solid Tumors, run by Hansoh BioMedical R&D Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of HS-20093 and free toxin (time frame: Three treatment cycles, each cycle lasting for three weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.